QP Associate — Global QA & Batch Release

SUN PHARMA; Hoofddorp; Sur place; EUR 80 000 - 110 000; Plein temps

Résumé du poste

Sun Pharmaceutical Industries Ltd. (Sun Pharma) seeks a QA compliance specialist to support external manufacturing quality and on-time product release worldwide.

You will ensure batch documentation meets GMP, coordinate with CMOs, and maintain quality systems aligned with QA agreements and regulatory expectations. The role covers risk management, deviations, change controls, CAPAs, and support for tech transfers, APR/PQR reviews, and audits.

Qualifications

• Bachelor level degree in (bio-)chemistry, pharmacy or similar field.
• 5+ years of relevant pharmaceutical experience in Drug Substance/Drug Product manufacturing.
• Strong knowledge of EU GMP and US CFRs.
• Proficient in Microsoft Excel.

Responsabilités

• Manage/Support weekly QA batch release planning and documentation for release.
• Review batch documentation for CoA/CoC and regulatory compliance.
• Lead/coordinate deviations, change controls, CAPAs, and complaints with CMOs and QA stakeholders.
• Run periodic quality meetings to monitor Change Controls, Deviations, and CAPAs with internal teams and CMOs.
• Support technology transfers, process/analytical method validation from QA perspective when needed.
• Prepare annual product reviews (APR/PQR) for biologics as required.
• Maintain product specifications aligned with marketing authorizations and update documentation.
• Review QP batch certification for clinical trial batches and ensure IND/IMP compliance.
• Manage CMO change notifications and communications per Quality Agreements.
• Apply risk management tools across the QMS to assess impact on product quality and compliance.
• Assist QA IT systems and support GAP assessments and audits readiness.

Connaissances

EU GMP knowledge

US CFRs knowledge

QA/QC understanding

Regulatory compliance

Cross-functional collaboration

Formation

HBO or Bachelor Degree in (Bio-) Chemistry, Pharmacy or similar

Outils

Microsoft Excel

Description du poste

Sun Pharmaceutical Industries Ltd. (Sun Pharma) seeks a QA compliance specialist to support external manufacturing quality and on-time product release worldwide.

You will ensure batch documentation meets GMP, coordinate with CMOs, and maintain quality systems aligned with QA agreements and regulatory expectations. The role covers risk management, deviations, change controls, CAPAs, and support for tech transfers, APR/PQR reviews, and audits.