Quality Control Investigation Manager

About the role

We are looking for a highly competent professional to lead quality control investigations within our pharmaceutical laboratory. The manager will support site‑wide investigations of out‑of‑specification (OOS), out‑of‑trend (OOT), deviations, market complaints and other non‑conformities, ensuring strict adherence to regulatory expectations and internal quality systems.

Key responsibilities

• Conduct and support investigations for quality events across the site.
• Collaborate with cross‑functional teams to identify root causes and define corrective and preventive actions (CAPA).
• Provide investigation‑related support during regulatory, vendor, third‑party and customer audits.
• Assist investigation teams across sites to maintain audit readiness and respond to audit findings.

Required profile

• Strong knowledge of laboratory testing for sterile and oral solid dosage forms.
• Good understanding of laboratory practices, QC instruments and troubleshooting.
• Experience handling and investigating non‑conformities.
• Proficiency in root cause analysis (RCA), CAPA and investigation documentation.
• Solid grasp of GLP, GMP, GDP and overall GxP compliance.
• Working knowledge of Veeva Vault, electronic document management systems (eDMS) and SAP.

Required skills

• Laboratory testing for sterile dosage forms
• Laboratory testing for oral solid dosage forms
• QC instrument troubleshooting
• Root cause analysis (RCA)
• CAPA implementation
• Investigation documentation
• GLP, GMP, GDP, GxP compliance
• Veeva Vault
• eDMS
• SAP