Senior QA Lead: Batch Release & Compliance

Prothya Biosolutions; Amsterdam; On-site; EUR 70,000 - 100,000; Full time

Benefits offered by this job

Holiday allowance

Year-end bonus

Private parking or good transport link

Job summary

Prothya Biosolutions seeks a QA professional to lead QP batch release preparation, batch record reviews and QMS governance. You will supervise QA Officers, interact with OMCL, and ensure timely regulatory documentation and CAPA follow-up.

Key responsibilities include deviations handling, CAPA investigations, and maintenance of GMP procedures. Strong GMP knowledge, Dutch/English proficiency, and proactive, analytical communication are essential for success.

Qualifications

• Bachelor or Master’s degree in Life Sciences or Pharmacy.
• HBO >2 yrs experience or MSc.
• Basic knowledge of GMP guidelines and experience with biological intermediates, drug substances and aseptic manufacturing preferred.
• Experience with TrackWise, MasterControl, SAP or similar.
• Dutch and English working proficiency; English writing skills.
• Proactive, analytical thinker with clear communication.

Responsibilities

• Batch release preparation and supervision of QA officers in communication with OMCL.
• Review batch records and ensure readiness for QP batch release (intermediates, Drug Substances, Drug Products and Finished Products).
• Support QA operations and CAPA management; track effectiveness and assist audits.
• Provide validation support, review equipment validations.
• Lead deviations, CAPA investigations, and regulatory documentation.
• Ensure GxP compliance and proper documentation across QA activities.

Skills

Analytical thinking

Clear communication

Proactive attitude

Education

Bachelor/Master in Life Sciences/Pharmacy

Tools

TrackWise

MasterControl

SAP

Job description

Prothya Biosolutions seeks a QA professional to lead QP batch release preparation, batch record reviews and QMS governance. You will supervise QA Officers, interact with OMCL, and ensure timely regulatory documentation and CAPA follow-up.

Key responsibilities include deviations handling, CAPA investigations, and maintenance of GMP procedures. Strong GMP knowledge, Dutch/English proficiency, and proactive, analytical communication are essential for success.