Senior Executive – Pharmaceutical Manufacturing

About the role

The Senior Executive will lead critical documentation and compliance activities within a pharmaceutical manufacturing environment. This position ensures that all batch records, protocols, and quality systems meet GMP and cGMP standards while supporting continuous improvement.

Key responsibilities

• Authorized signatory for Batch Manufacturing Records (BMR), BMR requisition, issuance logbooks, protocols, and risk assessments.
• Prepare, revise, and approve new BMRs and related documentation within defined timelines.
• Assist in change control, corrective action plans, and new equipment qualification.
• Maintain compliance with in‑process control instructions, SOPs, logbooks, and environmental monitoring systems (EMS).
• Generate daily production reports and monitor machine utilization.
• Train technicians and supervisors on updated BMRs, SOPs, and GMP requirements.
• Develop process performance qualification, validation protocols, failure mode effect analysis, 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 or related quality roles.
• Strong knowledge of GMP, cGMP, BMR handling, and documentation control.
• Ability to work independently and sign off critical quality documents.

Required skills

• Batch Manufacturing Record (BMR) preparation and review.
• Change control and corrective/preventive action management.
• SOP creation and maintenance.
• Environmental Monitoring System (EMS) operation.
• Process validation and qualification protocol development.
• Failure Mode Effect Analysis (FMEA) and risk assessment.
• GMP/cGMP compliance.