Syngene Drug Product Manufacturing Job – MSc Biotech Apply Online
Role: Production Operator -DP Production
Requisition ID 55655
Department: Biopharmaceutical Operations
Reporting to: Supervisor, DP Production
Job Location: Bengaluru, India
The Company
Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development and manufacturing services company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical sectors. Syngene’s 4500+ scientists offer both skills and the capacity to deliver great science, robust data management and IP security and quality manufacturing, at speed, to improve time-to-market and lower the cost of innovation. With a combination of dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, as well as 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA.
Syngene has recently acquired new drug product facility with high capacity vial lines for serving the customers for key regulatory market to enhance the DP commercial capabilities
The Role: Objective of this role as an associate of Drug product production in Syngene’s new manufacturing facility for injectables in dosage form of vials.
Key Result Areas
Role-specific:
- Active involvement in all drug product manufacturing activities.
- Perform error free operation by eliminating operational gaps in advance.
- Pre -execution activity: Area and equipment readiness and ready to work in shifts
- Ensure Data integrity
- Issuance of raw material /consumables and issuance batch records.
- Batch process operation /unit operation (including CIP, SIP and preparation of accessories), washing , filling and sealing operations and close monitoring of batch performance and data.
- Attend the training session of EHS, cGMP and HRD.
- Ensure process equipment’s/instruments are in Qualified in state.
- Verify PM, check the log books and ensure the clean room requirements in order to get line clearance from QA for batch execution.
- Active coordination with inter-depts. for sample submission, closure of documentation and timely execution and contribution for the assigned tasks.
- Perform on-line documentation, cGMP and GDP compliance in all the manufacturing activity, and timely closure of executed documents and batch records.
- Ensure the Quality system is followed in day today operations.
- Active trouble shooting to minimize the various risks prior to execution and during execution.
TECHNICAL /FUNCTIONAL SKILL:
- Experience in Drug product manufacturing-Autoclaving/ Formulation/ Aseptic process-Filling and sealing
- Good experience in regulatory approved plants
- Sound knowledge and awareness of GMP controls, Quality systems and regulatory aspects
- Experience on risk assessment tools and change management.
- Experience on the Equipment Qualification
WORK EXPERIENCE: 1 to 6 years of Industrial experience in reputed pharmaceutical organization with a commercial manufacturing operations (production).
Education and Experience: Diploma/B.Sc/B.Pharm /M pharm/ M.Sc- Biotech
Apply for this exciting opportunity here.
Keywords: Production Operator, Drug Product, Manufacturing, Biopharmaceutical, GMP Controls, Quality Systems, Pharmaceutical, Biotech. Syngene Drug Product Manufacturing Job – MSc Biotech Apply Online. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook
