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Senior Associate QA (GMP)Undutchables • Breda, The Netherlands
Senior Associate QA (GMP)

Senior Associate QA (GMP)

Undutchables • Breda, The Netherlands
9 dagen geleden
Functieomschrijving
Please note before applying: Only candidates who are already residing in a reasonable commuting distance to Breda and are in possession of a valid work permit for the Netherlands will be considered for this role. This role does NOT offer sponsorships options.

As a Senior Associate QA, you will provide hands-on quality support within the production environment at our client's site. You will play a key role in ensuring GMP compliance, supporting production teams, and reviewing batch documentation prior to product release.

Key responsibilities are:
  • 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 finished 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

The company will operate under a new shift structure from January 2027 onwards and 100% commitment is needed when applying for the role:
  • 2 early shift days
  • 2 late shift days
  • 2 night shift days
  • 4 consecutive days off (This rotation will then repeat on an ongoing basis)
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.
  • 30 Holidays.
  • 1 year contract through Undutchables.

Application Procedure

If you are interested in this vacancy, you can apply by clicking on the button above. By clicking on apply, you agree to our privacy commitment and terms and conditions. Your application will be sent directly to the recruiter in charge. IMPORTANT: if you are not yet registered with Undutchables we kindly ask you to do so. Your information will be handled in the strictest confidence and your CV will not be sent to a company unless you have given prior permission. Curious about how the recruitment process works within Undutchables, click here to read more.
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Senior Associate QA (GMP) • Breda, The Netherlands

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