Senior Executive – Pharmaceutical Manufacturing

About the role

We are seeking a Senior Executive to lead critical manufacturing documentation and compliance activities within a pharmaceutical production environment. The role involves authorising and verifying key records, ensuring GMP adherence, and supporting continuous improvement initiatives.

Key responsibilities

• Authorize and sign Batch Manufacturing Records (BMR), BMR requisition, issuance logbooks, protocols and risk assessments.
• Sign off as checker/verifier for finished product logbooks and related documents.
• Prepare new BMRs, revise existing BMRs, and ensure timely updates.
• Assist in change control, corrective action plans, and new equipment qualification.
• Maintain and monitor the Environmental Monitoring System (EMS) and daily production reports.
• Develop, update and train staff on SOPs, logbooks, protocols and GMP requirements.
• Prepare process performance qualification, validation protocols, FMEA and risk assessments.
• Participate in functional, cGMP and other mandatory trainings.

Required profile

• B.Pharm, M.Pharm or MSc in a relevant scientific discipline.
• Minimum 5 years of experience in pharmaceutical manufacturing, with 7+ years in senior roles preferred.
• Proven ability to sign off critical manufacturing documents and ensure regulatory compliance.
• Strong understanding of GMP, change control, and corrective/preventive action processes.

Required skills

• Batch Manufacturing Record (BMR) management
• Change Control and Corrective Action planning
• SOP development and training
• Environmental Monitoring System (EMS) operation
• Process validation and performance qualification
• Failure Mode Effects Analysis (FMEA) and risk assessment
• cGMP compliance