Quality Assurance Officer GMP Production
SIRE® Life Sciences
Quality Assurance Officer GMP Production
Samenvatting
Wat krijg je?
Wat ga je doen?
- Conduct final quality verification for orders
- Review batch records and documentation accuracy
- Manage and resolve production deviations
- Exercise authority to stop non-compliant production
- Provide GMP guidance to production staff
Wat verwachten wij?
- Opleiding in Pharmaceutical Sciences of Life Sciences
- 3 jaar QA ervaring in de farmaceutische sector
- Kennis van GMP, GDP en GCP regelgeving
- Ervaring met reviewen van batch records
Volledige vacaturetekst
Join a leading organization in pharmaceutical manufacturing where your precision ensures the safety of life-changing products. As a Quality Assurance Officer, you play a pivotal role in the GMP team by overseeing final packaging verifications and resolving production deviations. You will enjoy direct escalation authority to maintain high standards, collaborating closely with diverse departments. Step into this vital role and be the guardian of quality. Ready to make a real impact on patient safety?
The Company
A leading organization in the pharmaceutical manufacturing industry, committed to maintaining the highest quality standards in its production processes. The company values precision, compliance, and continuous improvement to ensure the safety and efficacy of its products.
Role Description
We are seeking a proactive and detail-oriented Quality Assurance Officer to join the GMP manufacturing team. This role is vital in ensuring that the packaging, labeling, and production processes meet strict quality and regulatory standards. The successful candidate will play a key part in maintaining quality, supporting compliance, and resolving issues in a fast-paced production environment.
Responsibilities
-Conduct final quality verification for all packaging and labeling orders before release.
-Review batch records and documentation to ensure data accuracy, compliance, and completeness.
-Manage and resolve deviations or quality issues during production.
Investigate, document, and follow up on deviations or non-compliance issues.
-Collaborate closely with Production, Maintenance, QA colleagues, and other departments to ensure smooth operations.
-Exercise escalation authority by stopping production if quality or compliance concerns arise.
-Provide guidance and support to production staff on GMP standards and procedures.
-Review and approve batch production records and deviation reports.
Requirements
-MBO or BSc degree in Pharmaceutical Sciences, Life Sciences, or a related field.
At least 3 years of experience in Quality Assurance or manufacturing within the ---pharmaceutical or medical device sector, with a focus on batch record review and investigations.
-Strong understanding of GMP, GDP, and GCP regulations, with the ability to interpret and apply them.
-Proven attention to detail and a methodical approach to quality and compliance tasks.
-Skilled team player with excellent communication skills and the confidence to challenge production when necessary.
-Fluency in English.
-Valid driver’s license is a plus.
Other Information
This role operates on a three-shift system, involving early, late, and night shifts, with no rotation. Shift hours are as follows:
58572
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