Specialist QA

Bedrijfsnaam: -
Plaatsingsdatum: 04/04/2019
Standplaats: -


SIRE® 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 Zuid-Holland Netherlands.The CompanyOur customer is one of the largest supplier of medicines in the Netherlands. This is a unique opportunity to work in one of the largest pharmaceutical companies in the world!

Role DescriptionIn this role you act as a Qualified person, you are responsible for releasing finished drug product lots while ensuring compliance with the requirements of the marketing authorization and good manufacturing practices. As a Specialist Plant QA, you provide guidance and direction to Production, Maintenance & Engineering and Quality staff regarding compliance with quality standards and procedures.

Responsibilities• You partner daily with production and engineering staff to support, enable and improve the production process
• You partner with production staff in performing risk analysis and the establishment of quality limits and requirements
• You own, review and approve production and plant QA related documents (e.g. SOPs, Forms, Training)
• You review and approve deviations and CAPA, initiate and own as needed.
• You perform impact assessment as part of change controls impacting production or QA processes
• You review and approve production equipment maintenance work orders
• You review and approve test protocols before use in production
• You perform GMP compliance checks in production
• You participate in internal audits and lead as appropriate
• Participate in regulatory inspections and partner audits
• You assist in development and delivery of GMP training for QA and production staff
• You lead and participate in Plant QA related projects/global QA initiatives as needed
• You lead and assist in various investigations as needed
• You assist in validation activities as needed including review and approval of validation documents

Requirements• Master’s in science in Pharmacy or equivalent
• Knowledgeable, skilled and eligible to fulfill the requirements of EU directive 2001/83/EC article 49 (Qualified Person).
• Thorough knowledge of the processes involved in clinical and commercial manufacturing (GMP), warehousing, supply chain, equipment engineering principles and validation
• Acquired practical experience in Good Manufacturing Practice (GMP) ideally in a Secondary Packaging manufacturing setting
• Fluent in English

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Windimi Post.




Plaatsingsdatum :
Referentienummer :
Standplaats :
Adres :
Postcode :
9723 HK
Opleidingsniveau :
Uren :
Nader te bepalen
Dienstverband :
Werkervaring :
< 1 jaar (starter)
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