One of our clients is looking for a QA Specialist for 40 hours a week with a duration of a year, beginning in January 2020 in Breda.
The QA specialist will provide QA guidance and support in the production area at ABR. You will perform batch record review of batches assembled, packaged and labelled at ABR and contract manufacturers. You will establish effective working relationships with Production, Warehouse, Maintenance and Engineering, QA Management and the Qualified Person.
You will provide daily guidance and support to Production staff in regards to compliance with Standard Operating Procedures and Work Instructions. You need to act as a first point of contact in case of production queries (quality related) during packaging and labelling 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 labelled at ABR and contract manufacturers in preparation for disposition by QP. You will be the author for operational SOP's and Work Instructions and you need to review operational SOP's and Work Instructions. You need to approve Maintenance Work Orders and test protocols before use in production. You will perform GMP compliance checks in production and assist in development and delivery of GMP training activities for QA and production staff. You will participate in QA production related projects as needed and assist in various investigations as needed. You will be responsible for preparation of weekly/monthly metrics. You will own and maintain departmental performance boards.
The team and shifts
You will be working in a team of 12 people with diverse backgrounds and nationalities. They are looking for an outgoing, multi-tasking medior with strong communication skills.
The job is based on 3 shifts (early, late and night)
- MBO or Bachelor's degree in Life Sciences.
- 3 years of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with experience in batch record review and investigations.
- Knowledge of GMP, GDP or GCP with the ability to interpret and apply in mainly routine cases.
- Manufacturing and/or Quality analytical processes and operations.
- Fluent in English language.
Are you the QA Specialist that I'm looking for? Please contact Femke Fokkema via 020 522 1588 or f.fokkema[at]realstaffing.com