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Senior Associate QA (GMP)
Posted 1 hour 29 minutes ago by Undutchables
4 750,00 € Monthly
Permanent
Not Specified
Other
Noord-Brabant, Breda, Netherlands, 4811 AA
Job Description
As a Senior Associate QA, you will provide hands-on quality support within the production environment at our client's ABR site. You will play a key role in ensuring GMP compliance, supporting production teams, and reviewing batch documentation prior to product release. Key responsibilities:
- Provide daily QA support and guidance to production teams
- Act as the first point of contact for quality-related questions during packaging and labeling
- Review and approve batch records before and after production
- Perform in-process checks during commercial production runs
- Compile and review batch documentation for Qualified Person (QP) disposition
- Conduct GMP compliance checks on the production floor
- Review, approve, and manage deviation records
- Initiate and own QA deviations where required
- Author and review SOPs and Work Instructions
- Support GMP training for QA and production staff
- Participate in investigations, projects, and continuous improvement initiatives
- Prepare weekly/monthly QA metrics and maintain performance boards
- Week 1: Night shift
- Week 2: Late shift
- Week 3: Early shift
- Week 4: Late shift
- Week 5: Early shift
- Early: 06:30 - 15:00
- Late: 14:30 - 23:00
- Night: 22:30 - 07:00
- MBO or Bachelor's degree in Life Sciences, Pharmaceutical Sciences, or related field
- Minimum 3 years of QA or manufacturing experience within pharma or medical devices
- Experience with batch record review and investigations
- Fluent in English
- Solid understanding of GMP (GDP/GCP knowledge is a plus)
- Experience in batch record review and deviation handling
- Familiarity with manufacturing and/or QA processes in pharma or medical devices
- Ability to interpret and apply regulatory requirements in day-to-day operations
- Analytical mindset with problem-solving capabilities
- Strong communication skills and ability to engage with multiple stakeholders
- Detail-oriented with strong administrative and documentation skills
- Able to prioritize and perform under pressure in a fast-paced environment
- Proactive, solution-driven mindset
- A challenging work environment with excellent career development programs.
- For this role, the company offers a competitive salary package.
- Reimbursement of travel expenses is dependable on travel distance.
- The contract will be through Undutchables.
Undutchables
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