Senior QA Officer – QMS, GMP & Batch Release Lead

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

Benefits offered by this job

Annual bonus

Holiday allowance

Training budget

Travel reimbursement

Pension plan

Good transport access

Job summary

Prothya Biosolutions seeks an experienced Senior QA Officer QMS to drive GMP compliance, support QP batch release activities, and maintain high-quality standards across manufacturing operations. You will collaborate with Manufacturing, Quality Control, Engineering, and Regulatory Affairs to ensure compliance and continuous improvement.

The role emphasizes QA operations, deviation handling, CAPA, audits, and staff training while coordinating with regulatory bodies to ensure inspection readiness.

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, or related field.
• Experience in GMP-regulated pharmaceutical or biotechnology environment.
• Experience in QA Operations, Batch Release, or Quality Systems preferred.
• Knowledge of EU GMP guidelines.
• Strong analytical and problem-solving skills.
• Experience with deviation management and CAPA processes.
• Strong communication and stakeholder management skills.
• Detail-oriented with strong documentation skills.
• Ability to work independently and within cross-functional teams.

Responsibilities

• Prepare QP batch release documentation for intermediates, Drug Substances, Drug Products, and Finished Products.
• Review and approve batch records.
• Physically release products in the warehouse.
• Ensure overall QMS compliance related to QA operational tasks.
• Supervise QA Officers or junior personnel where applicable.
• Coordinate with OMCL during required communications.
• Support extended Root Cause Analysis (RCA) using established methodologies.
• Review and closure of OOS, OOL, and OOT investigations.
• Assist investigations related to Product Quality Complaints.
• Handle returned goods and CAPA close-outs.
• Execute change controls and monitor related activities.
• Review and approve routine equipment validations.
• Assist validation activities where required.
• Act as SME during internal audits and customer inspections.
• Support regulatory audits and inspection readiness.
• Present processes during audits as required.
• Provide on-the-job training to QA Operations staff and support deviations, CAPA, and quality systems training.
• Write and review GMP procedures and GMP documentation (SOPs, Master Batch Records).
• Deliver quality data for monthly metrics and Quality Management Review.
• Support Product Quality Review documentation.
• Conduct routine shopfloor QA oversight visits.
• Coach junior team members and lead projects as SME.
• Assist Quality Lead in stakeholder management.

Skills

GMP knowledge

QA Operations

Batch Release

Deviations & CAPA

Root Cause Analysis

Documentation

Stakeholder Management

Training

Education

Bachelor’s or Master’s degree in Life Sciences/Pharmacy/Biotechnology

Related field expertise

Job description

Prothya Biosolutions seeks an experienced Senior QA Officer QMS to drive GMP compliance, support QP batch release activities, and maintain high-quality standards across manufacturing operations. You will collaborate with Manufacturing, Quality Control, Engineering, and Regulatory Affairs to ensure compliance and continuous improvement.

The role emphasizes QA operations, deviation handling, CAPA, audits, and staff training while coordinating with regulatory bodies to ensure inspection readiness.