Chemical Manager

About the role

The Chemical Manager will support the Quality Control Manager in overseeing QC activities related to Cleaning Validation, Computer System Validation, and the Annual Product Quality Review (PQR) process. This role ensures compliance with validation guidelines and drives continuous improvement across QC functions.

Key responsibilities

• Prepare and implement the annual PQR plan, collect and analyze data, and produce the PQR report.
• Develop Cleaning Validation Master Plans, protocols, and reports, and conduct cleaning validation and re‑validation activities.
• Maintain and execute the Computer System Validation Master Plan for QC equipment, preparing protocols and reports.
• Review and align SOPs and policies related to PQR, cleaning validation, and computer system validation.
• Support change control, impact and risk assessments, and provide data for stability programs.
• Participate as a subject‑matter expert in internal and external audits and implement audit CAPAs.

Required profile

• M.Sc. Chemistry or Pharm‑D with 8‑10 years of experience in QC/QA validation functions.
• Strong knowledge of cleaning validation, computer system validation, and annual product quality review processes.
• Experience in preparing validation master plans, protocols, reports, and risk assessments.

Required skills

• Cleaning Validation
• Computer System Validation
• Product Quality Review (PQR)
• Validation Master Planning
• Risk and impact assessment