A.M/Dy.M/Manager - MS & T(Injectables)

4 days ago


Hyderabad, Telangana, India Digvijaya Management Full time ₹ 20,00,000 - ₹ 25,00,000 per year

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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