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Quality Management Specialist

LocationHoofddorp, Netherlands
Business SectorBiotechnology
Contact email
Job ref26745
Publishedabout 2 hours ago

The QA/QMS consultant supports product quality compliance and batch release activities within Sun Pharma’s European operations. The role ensures Quality Management System (QMS) activities are audit-ready and that Contract Manufacturing Organizations (CMOs) operate in compliance with cGMP and established Quality Agreements. Responsibilities include batch documentation review, deviation and CAPA management, change control assessment, complaint handling, APR/PQR review, and quality data trending.

 

Non-Negotiable Skills, Qualifications, and Experience:

  • Bachelor’s degree (HBO or equivalent) in (Bio-)Chemistry, Pharmacy, Biotechnology, or a related scientific discipline
  • Minimum 5 years of experience in pharmaceutical manufacturing
  • Experience working within a GMP-regulated pharmaceutical manufacturing environment
  • Experience reviewing batch documentation for GMP compliance
  • Experience managing or supporting deviations, change controls, CAPAs, and product complaints
  • Experience working with CMOs
  • Experience reviewing Annual Product Reviews (APR) or Product Quality Reviews (PQR)
  • Fluency in English

 

Desirable Skills, Qualifications, and Experience:

  • Experience supporting batch release activities
  • Experience maintaining or supporting a QMS
  • Experience using risk management tools within a pharmaceutical quality environment
  • Experience trending and analyzing quality data
  • Experience supporting product specification management aligned with Marketing Authorizations
  • Experience supporting quality oversight across multiple international stakeholders
  • Experience working within European pharmaceutical regulatory environments

 

What the Assignment Offers:

  • QMS Specialist role focused on GMP compliance, batch review, and quality event management
  • Direct responsibility for deviations, CAPAs, change controls, and CMO oversight
  • Exposure to EU-regulated pharmaceutical release activities
  • 6–12 month freelance contract with strong extension potential
  • Clear operational scope in a production-driven environment
  • Immediate impact on quality performance and audit readiness

 

Interested in discussing this opportunity confidentially?

Maurits van Sloun

? m.vansloun@panda-int.com

? +31 20 204 4502

The QA/QMS consultant supports product quality compliance and batch release activities within Sun Pharma’s European operations. The role ensures Quality Management System (QMS) activities are audit-ready and that Contract Manufacturing Organizations (CMOs) operate in compliance with cGMP and established Quality Agreements. Responsibilities include batch documentation review, deviation and CAPA management, change control assessment, complaint handling, APR/PQR review, and quality data trending.

 

Non-Negotiable Skills, Qualifications, and Experience:

  • Bachelor’s degree (HBO or equivalent) in (Bio-)Chemistry, Pharmacy, Biotechnology, or a related scientific discipline
  • Minimum 5 years of experience in pharmaceutical manufacturing
  • Experience working within a GMP-regulated pharmaceutical manufacturing environment
  • Experience reviewing batch documentation for GMP compliance
  • Experience managing or supporting deviations, change controls, CAPAs, and product complaints
  • Experience working with CMOs
  • Experience reviewing Annual Product Reviews (APR) or Product Quality Reviews (PQR)
  • Fluency in English

 

Desirable Skills, Qualifications, and Experience:

  • Experience supporting batch release activities
  • Experience maintaining or supporting a QMS
  • Experience using risk management tools within a pharmaceutical quality environment
  • Experience trending and analyzing quality data
  • Experience supporting product specification management aligned with Marketing Authorizations
  • Experience supporting quality oversight across multiple international stakeholders
  • Experience working within European pharmaceutical regulatory environments

 

What the Assignment Offers:

  • QMS Specialist role focused on GMP compliance, batch review, and quality event management
  • Direct responsibility for deviations, CAPAs, change controls, and CMO oversight
  • Exposure to EU-regulated pharmaceutical release activities
  • 6–12 month freelance contract with strong extension potential
  • Clear operational scope in a production-driven environment
  • Immediate impact on quality performance and audit readiness

 

Interested in discussing this opportunity confidentially?

Maurits van Sloun

? m.vansloun@panda-int.com

? +31 20 204 4502