A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Sr. Executive PAC
Job Description
- Troubleshooting of variety of problems that occur during production process (science base and risk assessment base approach)
- Should have good technical understanding of solid oral dosage forms manufacturing process and Process equipment’s (Viz. Tablets , Capsules, pellets and modified release solid dosage forms)
- Preparation and review of Manufacturing and Packaging Documents for Execution of Validation and Exhibit Batches
- Execution and Monitoring of Scale up and Validation Batches of Increase batch size of commercial products.
- Execution and Monitoring of Scale up and Validation Batches of commercial products with Alternate source API’s and excipients.
- Product remediation and execution of reformulation batches on the shop floor (with help of SDC & TTG if required) COGS reduction projects (TPC reduction by process improvement; Alternate source; B. Size scale up etc.)
- Preparation of Project Approval Sheet, Post Approval Change Protocol and Initiation and Closure of Change Request.
- Collection, Assessment and Compilation of the Process Parameters/ Data Obtained during Scale up/Validation Batches.
- Review of manufacturing process, critical step, release specification etc. from dossier before finalized BMR & MFR.
- Ensure all the changes as per the CRF and cGMP
Candidate Profile
B.Pharm, M.Pharm, Ph.D English 5 years experience in case of Ph.D and 10 years incase of B.Pharm and 8-10 years in case of M.Pharm
Additional Information:
Experience: 5 years
Location: Navi Mumbai
Education: B.Pharm, M.Pharm, Ph.D
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Technical Operations
Division: Pharma
Job Type: Full Time
Employment Type: Regular
Job ID: 232444BR
End Date: 28th February, 2018
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