QA Specialist Packaging
- Breda
- 3500.00 - 5000.00
- 32-40 hours
- Bachelor degree
Client
Our client is a leading project management and engineering company serving the pharmaceutical industry around the world.
Client
Our client is a leading project management and engineering company serving the pharmaceutical industry around the world.
Requirements
- BSc degree in Pharmaceutical/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 English, Dutch preferred
What do you get?
- Pension entitlement as from day one
- Collective WGA / WIA insurance
- NBBU / ABU collective labor agreement
- 25 holidays days
- 8,33% holiday allowance
- 100% payment in case of illness after one waiting day
- Travel allowance
- Allowance for shifts
Duties
- Provide QA guidance and support in the production area.
- Perform batch record review of batches assembled, packaged and labeled.
- Establish effective working relationships with Production, Warehouse, Maintenance and Engineering, QA Management and the Qualified Person.
- Provide daily guidance and support to Production staff in regards to compliance with Standard Operating Procedures and Work Instructions.
- Act as a 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 in preparation for disposition by QP.
- Perform GMP compliance checks in production.
- Review and approve deviation records.
- Initiate and own QA deviations as needed.
- Act as author for operational SOP’s and Work Instructions, as needed.
- Review of operational SOP’s and Work Instructions, as needed.
- Assist in development and delivery of GMP training activities for QA and production staff.
- Participate in QA production related projects, as needed.
- Assist in various investigations, as needed.
- Assist projects and improvement efforts, as needed.
- Responsible for preparation of weekly/monthly metrics.
- Own and maintain departmental performance boards.
Please note: this is a 3-shift job.
- Early shift: 06.30 - 15.00
- Late shift: 14.30 - 23.00
- Night shift: 22.30 - 07.00
