Executive – Pharmaceutical Manufacturing

About the role

We are seeking an Executive to lead pharmaceutical manufacturing activities, ensuring compliance with GMP and driving continuous improvement in batch production processes. The role involves overseeing documentation, change control, and environmental monitoring within a regulated environment.

Key responsibilities

• Authorize and sign Batch Manufacturing Records (BMR), requisitions, issuance logbooks, protocols and risk assessments as a doer and verifier.
• Prepare new BMRs, revise existing ones, and ensure timely updates.
• Assist in change control, corrective action plans, and new equipment qualification.
• Maintain and monitor the Environmental Monitoring System (EMS), reviewing daily reports and alerts.
• Update SOPs, log books and train technicians and supervisors on revised procedures.
• Prepare process performance qualification, validation protocols, failure mode effect analysis and risk assessments.
• Generate daily production and machine utilization reports.
• Participate in functional, cGMP and other mandatory trainings.

Required profile

• B.Pharm, M.Pharm or MSc in a relevant scientific discipline.
• 5+ years of experience in pharmaceutical manufacturing, with exposure to GMP environments.
• Proven ability to sign off critical documentation and lead corrective and preventive actions.
• Strong understanding of change control, equipment qualification and process validation.

Required skills

• Batch Manufacturing Record (BMR) management
• Change Control and Corrective Action Planning
• Environmental Monitoring System (EMS) operation
• Standard Operating Procedures (SOP) development
• Good Manufacturing Practices (GMP) compliance
• Process Validation and Performance Qualification
• Failure Mode Effect Analysis (FMEA)
• Risk Assessment