For one of our clients in Breda we are urgently looking for a Senior Associate QA!
Do you have an overview in packaging?
Do you know how to inspect a production line?
Are you a problem solver who likes to improve processes?
Do you have GMP knowledge?
If this could be something for you, do not hesitate to apply today!
To provide QA guidance and support in the production area.
To perform batch record review of batches assembled, packaged and labeled at the client and contract manufacturers.
To establish effective working relationships with Production, Warehouse, Maintenance and Engineering, QA Management and the Qualified Person.
This job is 5 working days (Mon-Fri), in 3 shift operation: Early: 0630-1500 every other week, Late: 1430-2300 every other week and Night: 2230-0700, for now, every 8 weeks expected it will be more frequent in near future (e.g. every 4 to 5 weeks).
Provide daily guidance and support to Production staff in regards to compliance with Standard Operating Procedures and Work Instructions.
Act as the first point of contact in case of production queries (quality related) during packaging and labeling operations.
Review and approve batch production record data entries before production activities take place.
Perform finished product checks during (commercial) production runs.
Compile and review batch records for lots assembled, packaged and labeled at the company and contract manufacturers in preparation for disposition by QP.
Act as author for operational SOP’s and Work Instructions Review of operational SOP’s and Work Instructions Review and approve class I Non-Conformances.
Initiate and own QA Non-Conformances as needed.
Approve Maximo Work Orders.
Review and approve test protocols before use in production.
Perform GMP compliance checks in production.
Assist in development and delivery of GMP training activities for QA and production staff.
Responsible for the preparation of weekly/monthly metrics.
MBO or Bachelor’s degree in Life Sciences or related field or the equivalent combination of education and/or experience.
Typically 3 years of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with experience in batch record review and investigations.
Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/ or Good Clinical Practice (GCP) knowledge with the ability to interpret and apply in mainly routine cases.
Manufacturing and/or Quality analytical processes and operations.
Fluent in English language. Preferably good Dutch knowledge.
+32 15 21 11 04