Biologics QA Specialist | Batch Release & Compliance

SUN PHARMA; Hoofddorp; On-site; EUR 70,000 - 100,000; Full time

Benefits offered by this job

International environment

25 holidays + 1 extra day off on your…

Job summary

Sun Pharmaceutical Industries Ltd. seeks a QA Specialist Biologics to ensure compliant batch release and certification of biologics, including external manufacturing oversight. The role drives quality assurance across DS/DP processes and maintains Sun's QMS in alignment with regulatory expectations.

The candidate will collaborate with QP, QA/QA CMO teams, and cross-functional partners to secure timely product releases and uphold high quality standards in a global biologics environment.

Qualifications

• 5 years of relevant experience in (bio) pharmaceutical Drug Substance and/or Drug Product manufacturing.
• Strong knowledge of EU GMP, US CFRs.
• Good knowledge of MS Office tools, especially Excel.

Responsibilities

• Manage weekly QA batch release planning for Biologics products.
• Review batch documentation for release and ensure GMP compliance.
• Oversee deviations, change controls, CAPAs, and complaints with CMOs and Sun stakeholders.
• Prepare annual product reviews (APR/PQR) for Biologics products.
• Maintain product specifications and update related documentation.
• Support QP batch release for clinical trial batches when applicable.
• Assist with risk management, internal audits, and regulatory readiness.

Skills

Interpersonal skills

Communication

Negotiation

Cross-cultural teamwork

Education

Bio/chemistry or Pharmacy degree

Tools

Trackwise

Document Management

Training Systems

Job description

Sun Pharmaceutical Industries Ltd. seeks a QA Specialist Biologics to ensure compliant batch release and certification of biologics, including external manufacturing oversight. The role drives quality assurance across DS/DP processes and maintains Sun's QMS in alignment with regulatory expectations.

The candidate will collaborate with QP, QA/QA CMO teams, and cross-functional partners to secure timely product releases and uphold high quality standards in a global biologics environment.