03 Oct
|
Zydus Group
|
Ahmedabad
03 Oct
Zydus Group
Ahmedabad
Position
Executive / Senior Executive – Manufacturing Science & Technology (MS&T;)
Department
Manufacturing Science & Technology (MS&T;)
Qualification
- B.Pharm / M.Pharm / M.Sc. / B.Tech Biotechnology/Chemical Engineering
- 3 to 8 years of experience in sterile injectable manufacturing
Key Responsibilities
1. Technology Transfer
- Coordinate recent product and process technology transfer from R&D;/site transfer teams to commercial manufacturing.
- Review and prepare technology transfer documents, manufacturing instructions, and risk assessments.
- Support exhibit batches, engineering batches, and process qualification batches.
2. Process Validation
- Prepare and review Process Validation Protocols and Reports.
- Execute Process Performance Qualification (PPQ) activities.
- Perform continued process verification and trend analysis.
- Evaluate critical process parameters and critical quality attributes.
3. Manufacturing Support
- Provide scientific and technical support to production departments such as:
- Compounding
- Aseptic Filling
- Vial Washing
- Sterilization/Autoclave
- Lyophilization
- Investigate process deviations and recommend corrective actions.
- Support resolution of manufacturing issues and improve process robustness.
4. Risk Assessment & Investigation
- Participate in root cause analysis for deviations, OOS, OOT, complaints, and failures.
- Conduct risk assessments using tools such as FMEA and Fishbone Analysis.
- Prepare CAPA effectiveness evaluations.
5. Documentation & Compliance
- Prepare and review:
- Process validation documents
- Technical protocols and reports
- Change controls
- Risk assessments
- Product Quality Reviews (PQR/APR)
- Ensure compliance with cGMP, USFDA, MHRA, EU GMP, WHO, and other regulatory requirements.
6. Continuous Improvement
- Identify process improvement opportunities to enhance productivity and reduce rejection rates.
- Analyze process capability and manufacturing trends.
- Participate in Lean Manufacturing and Operational Excellence initiatives.
Job Snapshot
Updated Date
02-10-2026
Job ID
JOB11163
Division
FILL AND FINISH
Location
R&D; – ZRC|Fill & Finish, Ahmedabad, Gujarat, India
Experience
0 - 5 Years
Employee Type
P-P8-Probationer-HO Executive
📌 MS&T (Ahmedabad)
🏢 Zydus Group
📍 Ahmedabad