12 nov 2020
Quality Assurance Specialist
| Branche | Zie onder |
| Dienstverband | Uitzenden en detacheren |
| Uren | 32 - 40 uur |
| Locatie | Leiden |
| Salarisindicaties | 0-5.000 |
| Opleidingsniveau | HBO / bachelor |
| Organisatie | Modis |
| Contactpersoon |
Cindy van Gorp - Guldenaar 06-12781269 |
Informatie
Bedrijfsomschrijving
Our client is an international pharmaceutical company with two sites in the Netherlands. The Leiden site is mainly responsible for Pharmacovigilance, Regulatory and Medical activities.
Functieprofiel
Collaboration in further setup, maintenance and implementation of the pharmaceutical quality management system as well as performance of several measures to secure the quality management of the Affiliate and its third parties.
• To act as a deputy Responsible Person as defined in EU GDP Guideline 2013/C 343/01
• To perform Quality Assurance activities on behalf of the Affiliate in its capacity as wholesaler and Marketing Authorization Holder
• To ensure all Astellas products, personnel and third parties conform to local, European and company quality assurance requirements
• To ensure implementation and maintenance of a Quality Management System, which is compliant with EU GDP Guidelines, local legislation and Astellas corporate quality assurance requirements and is proportionate to the scope of wholesale distribution and Marketing Authorization Holder activities undertaken by or on behalf of the affiliate.
• To maintain independence with regards to QA decision making within the affiliate.
Essential Job Responsibilities
• Maintain the Quality Management System: implementation and continual improvement of QM systems, procedures and processes, i.e.: handling of deviations, complaints and CAPAs, handling of GMP/ GDP regulated changes or escalation of potential significant quality issues.
• Ensure that deviations and complaints, as identified at the affiliate are raised in TrackWise, are appropriately investigated and CAPA plans are developed where appropriate.
• Ensure deviations, complaints, CAPAs and change control actions are progressed in a timely manner.
• Maintain the training system for all personnel involved in wholesale dealer and/or MAH activities, and perform training of the relevant Quality Management Systems.
• Perform local checks following receipt of certified medicinal product according to a documented process and execute the local “Release for Distribution” for products in accordance with local regulations and guidelines.
• Check and prepare quality agreements with local country third parties in accordance with internal and external regulations.
• Perform audits of local country third parties, as appropriate.
• Conduct self-inspections according to the approved self-inspection plan.
• Ensure local GMP / GDP procedures are maintained in the Astellas Document Management Systems (ADMS).
• Ensure that only approved Local Service Providers are used, if applicable.
• Collaborate with LSPs to ensure Quality Assurance requirements are followed and maintain appropriate QA oversight for GDP operations and warehouse management.
• Properly document changes with potential impact on GDP/GMP compliance, ensure that changes are approved by the RP, and implement the changes in accordance with the agreed timelines.
• Perform validation activities for local GDP / GMP systems, as required.
• Review the Product Quality Review reports in a timely manner.
• Support the RP in case of SQI’s and recalls.
• Prepare for GDP/GMP Inspections by Competent Authorities, and assist the Quality Assurance Lead & Responsible Person during these inspections.
• Prepare for QA Internal audits, and assist the Quality Assurance Lead & Responsible Person during these internal audits
• Prepare monthly KPI report, ensure approval of the KPI report by the Quality Assurance Lead & Responsible Person, and submit the KPI report to the QA Subregion lead.
Bedrijfsprofiel
Our client is an international pharmaceutical company with two sites in the Netherlands. The Leiden site is mainly responsible for Pharmacovigilance, Regulatory and Medical activities.
Functie-eisenWe are looking for candidates with the following skill set:
• BSc/MSc Degree in a science/health-related subject and 2-3 years of Quality Assurance experience within the pharmaceutical industry
• Experienced in handling regulatory interfaces such as inspections and audits is an advantage
• Understanding of EU GDP, EU GMP and Quality Management Systems
• Ability to communicate and negotiate with peers
• Understanding of local and European regulatory environment
• Good organizational, coordination, diplomatic, negotiation, presentation and communications skills in English
• Precise, rigorous and reliable with an analytical mind
• Good decision making skills
• Computer literacy
Offer
Employment for 32 – 40 (preferred) hours per week starting at an innovative company. You will be working at a multidisciplinary team of Life Science professionals. You get the opportunity to develop your professional skills. Modis continues to innovate and stimulates new ways of working. In addition to getting a lot of freedom, you also get the necessary responsibilities. This way you are encouraged to continue to develop your ambitions and expertise. In this way we can grow together.
Connect Smarter.
More information
Do you want more information about this position? Please contact one of our Recruitment Consultants:
Cindy: 06–1278 1269
Lars: 06-1333 9633
Or send us an e-mail: technologylifescience@modis.com
How to apply
Please tell us who you are and what motivates you! Send us your using the application button on this website.
Our client is an international pharmaceutical company with two sites in the Netherlands. The Leiden site is mainly responsible for Pharmacovigilance, Regulatory and Medical activities.
Functieomschrijving
Functieprofiel
Collaboration in further setup, maintenance and implementation of the pharmaceutical quality management system as well as performance of several measures to secure the quality management of the Affiliate and its third parties.
• To act as a deputy Responsible Person as defined in EU GDP Guideline 2013/C 343/01
• To perform Quality Assurance activities on behalf of the Affiliate in its capacity as wholesaler and Marketing Authorization Holder
• To ensure all Astellas products, personnel and third parties conform to local, European and company quality assurance requirements
• To ensure implementation and maintenance of a Quality Management System, which is compliant with EU GDP Guidelines, local legislation and Astellas corporate quality assurance requirements and is proportionate to the scope of wholesale distribution and Marketing Authorization Holder activities undertaken by or on behalf of the affiliate.
• To maintain independence with regards to QA decision making within the affiliate.
Essential Job Responsibilities
• Maintain the Quality Management System: implementation and continual improvement of QM systems, procedures and processes, i.e.: handling of deviations, complaints and CAPAs, handling of GMP/ GDP regulated changes or escalation of potential significant quality issues.
• Ensure that deviations and complaints, as identified at the affiliate are raised in TrackWise, are appropriately investigated and CAPA plans are developed where appropriate.
• Ensure deviations, complaints, CAPAs and change control actions are progressed in a timely manner.
• Maintain the training system for all personnel involved in wholesale dealer and/or MAH activities, and perform training of the relevant Quality Management Systems.
• Perform local checks following receipt of certified medicinal product according to a documented process and execute the local “Release for Distribution” for products in accordance with local regulations and guidelines.
• Check and prepare quality agreements with local country third parties in accordance with internal and external regulations.
• Perform audits of local country third parties, as appropriate.
• Conduct self-inspections according to the approved self-inspection plan.
• Ensure local GMP / GDP procedures are maintained in the Astellas Document Management Systems (ADMS).
• Ensure that only approved Local Service Providers are used, if applicable.
• Collaborate with LSPs to ensure Quality Assurance requirements are followed and maintain appropriate QA oversight for GDP operations and warehouse management.
• Properly document changes with potential impact on GDP/GMP compliance, ensure that changes are approved by the RP, and implement the changes in accordance with the agreed timelines.
• Perform validation activities for local GDP / GMP systems, as required.
• Review the Product Quality Review reports in a timely manner.
• Support the RP in case of SQI’s and recalls.
• Prepare for GDP/GMP Inspections by Competent Authorities, and assist the Quality Assurance Lead & Responsible Person during these inspections.
• Prepare for QA Internal audits, and assist the Quality Assurance Lead & Responsible Person during these internal audits
• Prepare monthly KPI report, ensure approval of the KPI report by the Quality Assurance Lead & Responsible Person, and submit the KPI report to the QA Subregion lead.
Bedrijfsprofiel
Our client is an international pharmaceutical company with two sites in the Netherlands. The Leiden site is mainly responsible for Pharmacovigilance, Regulatory and Medical activities.
Functie-eisenWe are looking for candidates with the following skill set:
• BSc/MSc Degree in a science/health-related subject and 2-3 years of Quality Assurance experience within the pharmaceutical industry
• Experienced in handling regulatory interfaces such as inspections and audits is an advantage
• Understanding of EU GDP, EU GMP and Quality Management Systems
• Ability to communicate and negotiate with peers
• Understanding of local and European regulatory environment
• Good organizational, coordination, diplomatic, negotiation, presentation and communications skills in English
• Precise, rigorous and reliable with an analytical mind
• Good decision making skills
• Computer literacy
Offer
Employment for 32 – 40 (preferred) hours per week starting at an innovative company. You will be working at a multidisciplinary team of Life Science professionals. You get the opportunity to develop your professional skills. Modis continues to innovate and stimulates new ways of working. In addition to getting a lot of freedom, you also get the necessary responsibilities. This way you are encouraged to continue to develop your ambitions and expertise. In this way we can grow together.
Connect Smarter.
More information
Do you want more information about this position? Please contact one of our Recruitment Consultants:
Cindy: 06–1278 1269
Lars: 06-1333 9633
Or send us an e-mail: technologylifescience@modis.com
How to apply
Please tell us who you are and what motivates you! Send us your using the application button on this website.
Omschrijving
Bedrijfsomschrijving
Our client is an international pharmaceutical company with two sites in the Netherlands. The Leiden site is mainly responsible for Pharmacovigilance, Regulatory and Medical activities.
Functieprofiel
Collaboration in further setup, maintenance and implementation of the pharmaceutical quality management system as well as performance of several measures to secure the quality management of the Affiliate and its third parties.
• To act as a deputy Responsible Person as defined in EU GDP Guideline 2013/C 343/01
• To perform Quality Assurance activities on behalf of the Affiliate in its capacity as wholesaler and Marketing Authorization Holder
• To ensure all Astellas products, personnel and third parties conform to local, European and company quality assurance requirements
• To ensure implementation and maintenance of a Quality Management System, which is compliant with EU GDP Guidelines, local legislation and Astellas corporate quality assurance requirements and is proportionate to the scope of wholesale distribution and Marketing Authorization Holder activities undertaken by or on behalf of the affiliate.
• To maintain independence with regards to QA decision making within the affiliate.
Essential Job Responsibilities
• Maintain the Quality Management System: implementation and continual improvement of QM systems, procedures and processes, i.e.: handling of deviations, complaints and CAPAs, handling of GMP/ GDP regulated changes or escalation of potential significant quality issues.
• Ensure that deviations and complaints, as identified at the affiliate are raised in TrackWise, are appropriately investigated and CAPA plans are developed where appropriate.
• Ensure deviations, complaints, CAPAs and change control actions are progressed in a timely manner.
• Maintain the training system for all personnel involved in wholesale dealer and/or MAH activities, and perform training of the relevant Quality Management Systems.
• Perform local checks following receipt of certified medicinal product according to a documented process and execute the local “Release for Distribution” for products in accordance with local regulations and guidelines.
• Check and prepare quality agreements with local country third parties in accordance with internal and external regulations.
• Perform audits of local country third parties, as appropriate.
• Conduct self-inspections according to the approved self-inspection plan.
• Ensure local GMP / GDP procedures are maintained in the Astellas Document Management Systems (ADMS).
• Ensure that only approved Local Service Providers are used, if applicable.
• Collaborate with LSPs to ensure Quality Assurance requirements are followed and maintain appropriate QA oversight for GDP operations and warehouse management.
• Properly document changes with potential impact on GDP/GMP compliance, ensure that changes are approved by the RP, and implement the changes in accordance with the agreed timelines.
• Perform validation activities for local GDP / GMP systems, as required.
• Review the Product Quality Review reports in a timely manner.
• Support the RP in case of SQI’s and recalls.
• Prepare for GDP/GMP Inspections by Competent Authorities, and assist the Quality Assurance Lead & Responsible Person during these inspections.
• Prepare for QA Internal audits, and assist the Quality Assurance Lead & Responsible Person during these internal audits
• Prepare monthly KPI report, ensure approval of the KPI report by the Quality Assurance Lead & Responsible Person, and submit the KPI report to the QA Subregion lead.
Bedrijfsprofiel
Our client is an international pharmaceutical company with two sites in the Netherlands. The Leiden site is mainly responsible for Pharmacovigilance, Regulatory and Medical activities.
Functie-eisenWe are looking for candidates with the following skill set:
• BSc/MSc Degree in a science/health-related subject and 2-3 years of Quality Assurance experience within the pharmaceutical industry
• Experienced in handling regulatory interfaces such as inspections and audits is an advantage
• Understanding of EU GDP, EU GMP and Quality Management Systems
• Ability to communicate and negotiate with peers
• Understanding of local and European regulatory environment
• Good organizational, coordination, diplomatic, negotiation, presentation and communications skills in English
• Precise, rigorous and reliable with an analytical mind
• Good decision making skills
• Computer literacy
Offer
Employment for 32 – 40 (preferred) hours per week starting at an innovative company. You will be working at a multidisciplinary team of Life Science professionals. You get the opportunity to develop your professional skills. Modis continues to innovate and stimulates new ways of working. In addition to getting a lot of freedom, you also get the necessary responsibilities. This way you are encouraged to continue to develop your ambitions and expertise. In this way we can grow together.
Connect Smarter.
More information
Do you want more information about this position? Please contact one of our Recruitment Consultants:
Cindy: 06–1278 1269
Lars: 06-1333 9633
Or send us an e-mail: technologylifescience@modis.com
How to apply
Please tell us who you are and what motivates you! Send us your using the application button on this website.
Our client is an international pharmaceutical company with two sites in the Netherlands. The Leiden site is mainly responsible for Pharmacovigilance, Regulatory and Medical activities.
Functieomschrijving
Functieprofiel
Collaboration in further setup, maintenance and implementation of the pharmaceutical quality management system as well as performance of several measures to secure the quality management of the Affiliate and its third parties.
• To act as a deputy Responsible Person as defined in EU GDP Guideline 2013/C 343/01
• To perform Quality Assurance activities on behalf of the Affiliate in its capacity as wholesaler and Marketing Authorization Holder
• To ensure all Astellas products, personnel and third parties conform to local, European and company quality assurance requirements
• To ensure implementation and maintenance of a Quality Management System, which is compliant with EU GDP Guidelines, local legislation and Astellas corporate quality assurance requirements and is proportionate to the scope of wholesale distribution and Marketing Authorization Holder activities undertaken by or on behalf of the affiliate.
• To maintain independence with regards to QA decision making within the affiliate.
Essential Job Responsibilities
• Maintain the Quality Management System: implementation and continual improvement of QM systems, procedures and processes, i.e.: handling of deviations, complaints and CAPAs, handling of GMP/ GDP regulated changes or escalation of potential significant quality issues.
• Ensure that deviations and complaints, as identified at the affiliate are raised in TrackWise, are appropriately investigated and CAPA plans are developed where appropriate.
• Ensure deviations, complaints, CAPAs and change control actions are progressed in a timely manner.
• Maintain the training system for all personnel involved in wholesale dealer and/or MAH activities, and perform training of the relevant Quality Management Systems.
• Perform local checks following receipt of certified medicinal product according to a documented process and execute the local “Release for Distribution” for products in accordance with local regulations and guidelines.
• Check and prepare quality agreements with local country third parties in accordance with internal and external regulations.
• Perform audits of local country third parties, as appropriate.
• Conduct self-inspections according to the approved self-inspection plan.
• Ensure local GMP / GDP procedures are maintained in the Astellas Document Management Systems (ADMS).
• Ensure that only approved Local Service Providers are used, if applicable.
• Collaborate with LSPs to ensure Quality Assurance requirements are followed and maintain appropriate QA oversight for GDP operations and warehouse management.
• Properly document changes with potential impact on GDP/GMP compliance, ensure that changes are approved by the RP, and implement the changes in accordance with the agreed timelines.
• Perform validation activities for local GDP / GMP systems, as required.
• Review the Product Quality Review reports in a timely manner.
• Support the RP in case of SQI’s and recalls.
• Prepare for GDP/GMP Inspections by Competent Authorities, and assist the Quality Assurance Lead & Responsible Person during these inspections.
• Prepare for QA Internal audits, and assist the Quality Assurance Lead & Responsible Person during these internal audits
• Prepare monthly KPI report, ensure approval of the KPI report by the Quality Assurance Lead & Responsible Person, and submit the KPI report to the QA Subregion lead.
Bedrijfsprofiel
Our client is an international pharmaceutical company with two sites in the Netherlands. The Leiden site is mainly responsible for Pharmacovigilance, Regulatory and Medical activities.
Functie-eisenWe are looking for candidates with the following skill set:
• BSc/MSc Degree in a science/health-related subject and 2-3 years of Quality Assurance experience within the pharmaceutical industry
• Experienced in handling regulatory interfaces such as inspections and audits is an advantage
• Understanding of EU GDP, EU GMP and Quality Management Systems
• Ability to communicate and negotiate with peers
• Understanding of local and European regulatory environment
• Good organizational, coordination, diplomatic, negotiation, presentation and communications skills in English
• Precise, rigorous and reliable with an analytical mind
• Good decision making skills
• Computer literacy
Offer
Employment for 32 – 40 (preferred) hours per week starting at an innovative company. You will be working at a multidisciplinary team of Life Science professionals. You get the opportunity to develop your professional skills. Modis continues to innovate and stimulates new ways of working. In addition to getting a lot of freedom, you also get the necessary responsibilities. This way you are encouraged to continue to develop your ambitions and expertise. In this way we can grow together.
Connect Smarter.
More information
Do you want more information about this position? Please contact one of our Recruitment Consultants:
Cindy: 06–1278 1269
Lars: 06-1333 9633
Or send us an e-mail: technologylifescience@modis.com
How to apply
Please tell us who you are and what motivates you! Send us your using the application button on this website.
