Pharma Supervisor Drug Product Facility at Syngene, Apply Online
Designation: Supervisor – DP Production
Job Location: Bengaluru, India
Requisition ID: 55654
Reporting to: Production Head
Department: Biopharmaceutical Operations
About Syngene International Ltd.
Syngene International Ltd. is an integrated research, development, and manufacturing services company serving various sectors such as pharmaceuticals, biotechnology, nutrition, and more. With a team of over 4500 scientists, Syngene offers great science, data management, IP security, and quality manufacturing to improve time-to-market and lower the cost of innovation.
Company Overview
Syngene has recently acquired a new drug product facility with high-capacity vial lines to enhance its DP commercial capabilities for key regulatory markets.
Role Objective
The objective of this role: To supervise drug product production in Syngene’s new manufacturing facility for injectables – vial lines.
Key Result Areas
Role-specific responsibilities:
- Supervising and actively participating in all drug product manufacturing activities.
- Ensuring smooth operations by proactively identifying and addressing operational gaps
- Planning, scheduling, and attending shift activities
- Batch process operation/unit operation (including CIP, SIP and preparation of accessories), operation of production equipment’s and close monitoring of batch performance and data.
- Ensuring data integrity and attending training sessions on EHS, cGMP, and HRD
- Ensure process equipment’s/instruments are in Qualified state.
- Ensure the clean room requirements in order to manufacture aseptic products
- Active coordination with other departments, closure of documentation and timely execution and contribution for the assigned tasks.
- Perform on-line documentation, cGMP compliance in all the manufacturing activity, and timely closure of executed documents and batch records with GDP.
- Upholding the quality system in daily operations.
- Proactively troubleshooting to minimize risks before and during execution.
- Ensuring preventive maintenance and adherence to SOPs for equipment and line operation.
- Meeting production targets and implementing improvements as needed.
- Adhering to the Quality Management System and preparing production reports.
- Candidates must be willing to work in all shifts.
Technical Skills
- Experience in manufacturing drug products, including autoclaving, formulation, and aseptic filling and sealing processes.
- Extensive supervisory experience in regulatory-approved facilities.
- Strong understanding and familiarity with GMP controls, quality systems, and regulatory requirements.
- Proficiency on risk assessment tools and change management
- Expertise in equipment qualifications and conducting media fill simulations.
- Hands-on experience with terminal sterilization activities.
Work Experience
Industrial experience: 6 to 12 years in reputed pharmaceutical organizations with a commercial injectables manufacturing operation
Education and Experience
Qualifications: B.Pharm/M.Pharm/M.Sc in Biotech
