Description
JOB DESCRIPTION
The role is responsible for planning, supervising, and controlling pharmaceutical packaging operations to ensure safe, compliant, and efficient product packing in line with cGMP (current Good Manufacturing Practices). The role oversees primary, secondary, and tertiary packaging activities, ensuring adherence to approved BMR (Batch Manufacturing Record) and BPR (Batch Packing Record). The role ensures Good Documentation Practices (GDP – Good Documentation Practices), data integrity, and regulatory compliance across packaging lines. This position focuses on line clearance, in-process checks, reconciliation, and defect prevention while driving operational efficiency, manpower utilization, and audit readiness. The role plays a critical part in delivering right-first-time packaging output without compromising quality, safety, or compliance.
Essential Functions
- Manage and supervise packaging operations on the manufacturing shopfloor
- Ensure compliance with cGMP (current Good Manufacturing Practices) and GMP & Regulatory Compliance (Good Manufacturing Practices and Regulatory Compliance)
- Oversee execution and review of BMR (Batch Manufacturing Record) and BPR (Batch Packing Record)
- Ensure effective Line Clearance and Readiness before and after batch execution
- Monitor Batch Setting, Challenge Tests & Reconciliation activities
- Ensure compliance with Labeling, Barcoding, and Serialization requirements
- Drive Change Control & Deviation Management and support Investigation Analysis
- Oversee In-Process Checks and IPQC (In-Process Quality Control) coordination
- Ensure Rejection Handeling and yield reconciliation accuracy
- Maintain Good Documentation Practices (GDP – Good Documentation Practices)
- Ensure Safety & Hygiene Practices and Environmental, Health & Safety (EHS) compliance
- Develop team capability through Training and Competency Management
Additional Responsibilities
QUALIFICATIONS
Education
- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred
Experience:
- 10 years or more in 10 - 12 Years
Specialized Knowledge: Licenses:
