Manager Release CQ // Noord-Holland // Pharmaceutical
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 organisation, based in Noord-Holland Netherlands.
- Ensure GMP & GDP compliance at the commercial unit
- Maintain SOP’s and work instructions
- Ensure GMP & GDP training at local level
- Initiate continuous improvement of processes
- Lead Local Cross functional Quality Council
- Ensure market release based on batch release documentation
- Ensure GDP compliance on the distribution
- Ensure quality compliants are registered and followed-up
- Change control, deviations and CAPA’s
- Ensure quality agreements with suppliers and 3rd party service providers
- Msc in Pharmacy, Medicines, Biology or equivalent
- Minimum of 2 years experience as Quality Manager/QP in a pharmaceutical environment
- In-depth knowledge of cGMP & GxP regulations
- Experience with Quality Systems and risk assessment tools
- Fluent English communication
The Company
This organisation is specialized in the production of generic medicines and looking for an experience QA Manager to strengthen their Quality Center and ensure the quality release activities.Role Description
In this position you are responsible for the quality release activities and ensuring the products are efficiently distributed into the Netherlands and the EU, according to regional and local standards. In addition you will manage the Commercial Quality Release Team.Responsibilities
As the Release Manager you'll:- Ensure GMP & GDP compliance at the commercial unit
- Maintain SOP’s and work instructions
- Ensure GMP & GDP training at local level
- Initiate continuous improvement of processes
- Lead Local Cross functional Quality Council
- Ensure market release based on batch release documentation
- Ensure GDP compliance on the distribution
- Ensure quality compliants are registered and followed-up
- Change control, deviations and CAPA’s
- Ensure quality agreements with suppliers and 3rd party service providers
Requirements
We're looking for a professional with:- Msc in Pharmacy, Medicines, Biology or equivalent
- Minimum of 2 years experience as Quality Manager/QP in a pharmaceutical environment
- In-depth knowledge of cGMP & GxP regulations
- Experience with Quality Systems and risk assessment tools
- Fluent English communication
Other information
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