Senior QA Associate – Pharmaceutical Industry - Undutchables

Jobster

Breda

On-site

EUR 60,000 - 75,000

Full time

2 days ago
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Benefits offered by this job

Undutchables contract
Pension plan
Travel reimbursements
Development opportunities

Job summary

Jobster in Breda, Netherlands seeks a Senior Quality Assurance Associate – Clinical Supply Chain to ensure GMP, GDP and GCP compliance across packaging, labeling, storage and distribution of clinical trial products. You will collaborate with Production, Warehouse, Supply Chain, QA and Regulatory Affairs to maintain quality throughout the process.

Please note visa sponsorship is not available and relocation is only considered with secured accommodation within commuting distance.

Qualifications

  • Master's degree in Life Sciences, Pharmaceutical Sciences, Biotechnology or a related field.
  • Approximately 3 years of relevant experience in Quality Assurance or manufacturing within the pharmaceutical/medical device industry.
  • Experience with batch record reviews, quality investigations and/or analytical testing.
  • Good knowledge of GMP, GDP and/or GCP.

Responsibilities

  • Review batch documentation to support certification and release of investigational medicinal products per EU and international regulations.
  • Review and approve clinical trial label artwork for regulatory compliance.
  • Assess temperature deviations during transportation and storage at clinical sites.
  • Investigate and resolve quality and compliance issues in manufacturing and distribution of clinical products.
  • Review and approve minor deviations, ensuring procedures and regulatory requirements are followed.
  • Create, update and review SOPs and Work Instructions.
  • Prepare monthly quality reports and monitor KPIs.
  • Collaborate with departments to identify quality risks and implement improvements.
  • Provide hands‑on QA support during clinical packaging and labeling activities, including packaging checks and batch record reviews.
  • Perform QA checks to ensure GMP and GDP standards are maintained.

Skills

Quality Assurance
GMP/GDP/GCP
English (C1)
Analytical thinking
Problem solving
Communication
Ownership

Education

Master's degree in Life Sciences

Job description

As a Senior Quality Assurance Associate – Clinical Supply Chain, you will be responsible for ensuring that medicines used in clinical trials meet the required quality and regulatory standards. You will oversee quality processes related to the packaging, labelling, storage and distribution of clinical trial products. You will also work closely with departments such as Production, Warehouse, Supply Chain, Quality and Regulatory Affairs to ensure compliance throughout the entire process.

Please note that we are unable to consider candidates who require visa sponsorship or who live too far from the work location. Candidates who would need to relocate can only be considered if they have already secured accommodation within a reasonable commuting distance.

Your main responsibilities will include:
  • Reviewing batch documentation to support the certification and release of investigational medicinal products in accordance with EU and international regulations.
  • Reviewing and approving clinical trial label artwork to ensure compliance with regulatory requirements.
  • Assessing temperature deviations during transportation and storage at clinical sites.
  • Investigating and resolving quality and compliance issues related to the manufacturing and distribution of clinical products.
  • Reviewing and approving minor deviations, ensuring that all procedures and regulatory requirements are followed.
  • Creating, updating and reviewing Standard Operating Procedures (SOPs) and Work Instructions.
  • Preparing monthly quality reports and monitoring key performance indicators.
  • Collaborating with different departments to identify quality risks and implement improvements.
  • Providing hands‑on Quality Assurance support during clinical packaging and labelling activities, including packaging checks, batch record reviews and resolving quality‑related issues.
  • Performing QA compliance checks to ensure that GMP and GDP standards are consistently maintained.
Requirements
  • A Master's degree in Life Sciences, Pharmaceutical Sciences, Biotechnology or a related scientific field.
  • Approximately 3 years of relevant experience in Quality Assurance or manufacturing within the pharmaceutical or medical device industry.
  • Experience with batch record reviews, quality investigations and/or analytical testing.
  • Good knowledge of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/or Good Clinical Practice (GCP).
  • Excellent English communication skills, both written and spoken (C1 level).
  • Strong attention to detail and a quality-focused mindset.
  • Good analytical and problem‑solving skills.
  • The ability to communicate effectively and collaborate with different departments.
  • A proactive attitude, willingness to learn and ability to take ownership of responsibilities.
  • Currently residing in the Netherlands or within a reasonable commuting distance of Breda
Benefits
  • This is a 1-year contract position through Undutchables
  • Working hours: Full-time (40 hours/week)
  • Competitive salary package.
  • Pension scheme
  • Travel expense reimbursement, dependent on distance.
  • Dynamic, international, and collaborative work environment with excellent development opportunities.
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