Senior QA Associate – Pharmaceutical Industry

Undutchables; Breda; On-site; EUR 65,000 - 90,000; Full time

Job summary

Undutchables is seeking a Senior Quality Assurance Associate – Clinical Supply Chain to ensure medicines used in clinical trials meet quality and regulatory standards. You will oversee QA processes for packaging, labeling, storage and distribution, collaborating with Production, Warehouse, Supply Chain, Quality and Regulatory Affairs to maintain compliance across the full product lifecycle.

In addition, you will review documentation, approve artwork, monitor storage conditions, investigate

Qualifications

• Experience in QA for clinical trial products.
• Familiarity with GMP/GDP standards.
• Ability to review batch documentation for release.
• Collaborative with cross-functional teams (Production, QA, Regulatory).

Responsibilities

• Review batch documentation to support release of investigational products.
• Review and approve clinical trial label artwork for regulatory compliance.
• Assess temperature deviations during transportation and storage.
• Investigate quality and compliance issues in manufacturing and distribution.
• Prepare monthly quality reports and monitor KPIs.
• Create and update SOPs and work instructions.
• Provide hands-on QA support during packaging and labeling activities.
• Perform QA checks to ensure GMP and GDP standards.
• Collaborate with departments to identify quality risks and improvements.

Skills

Quality Assurance

Regulatory compliance

GMP

GDP

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.
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.

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.