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

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

Digvijaya Management

8 - 10 years

10 - 14 Lacs

Hyderabad

Posted:1 month ago| Platform:

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Skills Required

MS & T

Work Mode

Work from Office

Job Type

Full Time

Job Description

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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Digvijaya Management

Management Consulting

Mumbai

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