Senior Manager Quality - Temporary - 3 months (with a chance of extension) - fulltime
Location: NetherlandsSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical and Chemicals organisation, based in Noord-Holland Netherlands.
- External and Internal auditing of GxP Vendors within Europe
- Review and approval of internal and external GMDP Deviations and CAPAs
- Providing QA advice to other functions (Commercial, Regulatory CMC, IMP/Clinical supplies, Supply Chain,Generation, review and approval of GMDP, SOPs, Change Controls, CAPAs, Deviation Investigations, OOS/OOE/OOT investigations, Quality/Technical Agreements, Internal Quality Agreements)
- Supporting global projects (eQMS, eDMS, eLMS)
- Quality Systems Support (Implementing, maintaining and improving GxP Quality Sustems for Europe
- Drive improvements to the training systems and promote training compliance
- Establishment and monitoring of key metrics for Quality Systems
- Ensuring management oversight of the performance of Quality Systems for Europe
- Driving compliance within our GxP Quality Systems through effective monitoring and communication
- Background in Chemistry / small molecule GMP is required (technical small molecule GMP input will be required)
- 5+ years of QA experience in the pharmaceutical industry
- MS Office
- Fluency in English
- Experience in GxP Quality Systems and GMDP Compliance
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Bram Reulen.
The Company
They are a research-driven pharmaceutical company and focus to bring the highest value on patient care.Role Description
You will provide support to the Quality Systems and GMDP Compliance functions within the Quality department of Europe and aid in the development of a Global Quality culture and way of working within the company.Responsibilities
- GMDP Compliance Support- External and Internal auditing of GxP Vendors within Europe
- Review and approval of internal and external GMDP Deviations and CAPAs
- Providing QA advice to other functions (Commercial, Regulatory CMC, IMP/Clinical supplies, Supply Chain,Generation, review and approval of GMDP, SOPs, Change Controls, CAPAs, Deviation Investigations, OOS/OOE/OOT investigations, Quality/Technical Agreements, Internal Quality Agreements)
- Supporting global projects (eQMS, eDMS, eLMS)
- Quality Systems Support (Implementing, maintaining and improving GxP Quality Sustems for Europe
- Drive improvements to the training systems and promote training compliance
- Establishment and monitoring of key metrics for Quality Systems
- Ensuring management oversight of the performance of Quality Systems for Europe
- Driving compliance within our GxP Quality Systems through effective monitoring and communication
Requirements
- Degree in Chemistry or related area- Background in Chemistry / small molecule GMP is required (technical small molecule GMP input will be required)
- 5+ years of QA experience in the pharmaceutical industry
- MS Office
- Fluency in English
- Experience in GxP Quality Systems and GMDP Compliance
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Bram Reulen.
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