Senior Associate QA (GMP)

Posted 3 hours 4 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
This role operates in a 3-shift rotation, and full commitment is essential:
  • Week 1: Night shift
  • Week 2: Late shift
  • Week 3: Early shift
  • Week 4: Late shift
  • Week 5: Early shift
Shift hours:
  • Early: 06:30 - 15:00
  • Late: 14:30 - 23:00
  • Night: 22:30 - 07:00
Requirements Requirements:
  • 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
Benefits
  • 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.
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