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Quality Assurance
1 maand geleden
I’m looking for a **Sr. Associate QA - shift work**
- Provide QA guidance and support in the production area at ABR.
- Perform batch record review of batches assembled, packaged and labeled at ABR.
- Establish effective working relationships with Production, Warehouse, Maintenance and Engineering, QA Management and the Qualified Person.
**RESPONSIBILITIES**:
- Provide daily guidance and support to Production staff in regard 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 at ABR 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 an author for operational SOPs and Work Instructions, as needed.
- Review of operational SOPs and Work Instructions, as needed.
- Assist in the 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 in ABR projects and improvement efforts, as needed.
- Responsible for the preparation of weekly/monthly metrics.
- Own and maintain departmental performance boards.
**PROFILE**:
- 3 years of related QA OR manufacturing experience in the pharmaceutical or medical device industry with experience in batch record review and investigations.
- Manufacturing and/or Quality analytical processes and operations.
**EXTRA INFO**:
We are looking for an outgoing, multi-tasking mediator with strong communication skills and the ability to work under pressure. GMP experience is a plus. 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.
- **Location**:Breda
- **Salary** (including the holiday allowance and the shift allowance) starts from the 69 250 EUR gross/year
- **30 vacation days**:
- **Long-term contract**
Let's get in touch ASAP. Know someone interested? Introduce me to her or him. Refer a friend and earn €250,-.
Pay: €50.000,00 - €60.000,00 per year
Work Location: In person
