QP (12 Month Contract)

Purpose of the position

As QP, you are end responsible for certifying and releasing the produced batches of medicine. Your main goal is to ensure that every batch of medicines are produced, examined and stored according to relevant legislation and marketing authorizations.

Job requirements

• WO degree, in the field of pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology or biology (according to article 51 of the European Commission’s directive 2011/83/EC)
• Fluent in English is essential
• 1-2 years of relevant work experience as a QP
• Required to pass all the offered GMP and GDP courses
• Basic knowledge of and experience with MS Office programs
• Experience in a Pharmaceutical Production environment is desirable
• At least 6 months of acquired practical experience within this or another company with a GMP license in order to be permitted to release batches
• Monitoring the adherence to the requirements of the Good Manufacturing Practice (GMP)
• Creating, operating and maintaining the quality management system
• Responsible for evaluating and approving manufacturing documentation and Batch Journal, as well as keeping it for the prescribed time
• Responsible for checking that Batch Journals are complete prior to the release
• Ensure that products which do not meet requirements are not distributed
• Responsible for releasing batches of produced medicines for clinical use
• Responsible for the safe storage of the batch journals and reference and retention samples
• (co-)Coordinate site inspection by national authorities
• Final approval of manufacturing documentation and other GMP documents

Control

• Responsible for performing internal audits and external audits at sites of contract manufactures
• Monitor, give guidance, as well as give the final approval for deviations, CAPA’s and Change Controls

Operations

• Monitoring the adherence to the requirements of the Good Manufacturing Practice (GMP)
• Responsible for evaluating and approving manufacturing documentation and Batch Journal, as well as keeping it for the prescribed time
• Responsible for checking that Batch Journals are complete prior to the release
• Ensure that products which do not meet requirements are not distributed
• Responsible for releasing batches of produced medicines for clinical use
• Responsible for the safe storage of the batch journals and reference and retention samples
• (co-)Coordinate site inspection by national authorities
• Final approval of manufacturing documentation and other GMP documents

Systems

• Creating, operating and maintaining the quality management system
• Responsible for performing internal audits and external audits at sites of contract manufactures
• Monitor, give guidance, as well as give the final approval for deviations, CAPA’s and Change Controls