A.M/Dy.M/Manager - MS & T(Injectables)
3 days ago
Candidate should be B.Pharmacy/M.Pharmacy with 8-10 years of experience in Manufacturing Science and Technology from a reputed Injectable Industry for regulated markets.
Technology Transfer:
- Lead tech transfer of injectable formulations from R&D to manufacturing.
- Collaborate with formulation development, QA, QC, production, and engineering teams.
- Prepare and review technology transfer documents (TT protocols, reports, BMRs, etc.).
2. Process Optimization:
- Evaluate and optimize manufacturing processes for yield, cost, and quality improvements.
- Analyze critical process parameters (CPPs) and critical quality attributes (CQAs).
- Drive scale-up and process robustness studies.
3. Process Validation:
- Support the preparation and execution of process validation protocols (PV).
- Review and interpret process data for validation outcomes.
- Address any deviations, CAPAs, and improvement plans.
4. Troubleshooting and Technical Support:
- Provide on-the-floor technical support during manufacturing.
- Investigate and resolve process-related deviations and batch failures.
- Conduct root cause analysis and implement preventive measures.
5. Continuous Improvement:
- Identify and implement process improvements and cost-saving initiatives.
- Utilize tools like QbD, DOE, FMEA, and Six Sigma for problem-solving and process enhancement.
- in-depth knowledge of aseptic/sterile injectable manufacturing processes (lyophilization, terminal sterilization, SVP/LVP, etc.).
- Familiarity with cGMP, ICH, USFDA, EU GMP guidelines.
- Strong analytical and problem-solving skills.
- Good documentation and communication skills.
- Experience with statistical tools and data analysis is a plus.
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