Job Description:
Key Responsibilities:
In this role the new Process Engineer will be responsible for, but are not limited to:
1. Develops processes and controls that can support manufacturing of different types of sterile products
e.g. potent products, aseptic liquids/lyophilized, suspensions and sustained release products
2. Author and review technical protocols, process validation reports, manufacturing instructions, product impact
assessments, and regulatory sections in support of ANDA and marketing application submissions
3. Application of scientific and engineering principles to develop process understanding and scale up from laboratory
to commercial scale
4. Develop solutions to technical problems during process characterization and aseptic manufacturing
5. Serve as the aseptic fill//finish process expert for one or more commercial process introductions or process transfers
into Dr Reddys or external manufacturing network
6. Provide ongoing support to commercial fill/finish manufacturing operations through process capability analysis,
troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements
7. Should independently execute submission batch and possess sound knowledge of Process and TS validation
8. Selection of equipment and process train for optimal manufacturing process (quality and cost)
9. To enable the technology absorption and transfer of various sterile injectable products.
10. Should support the USFDA and regulatory audits
11. Consistently make independent decisions within the work group
12. Participate and lead cross-functional teams working effectively in a team environment to drive change, efficiency,
and strong relationships.
Salary: INR 9,00,000 – 19,00,000 P.A. Negotiable
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: Research Scientist
Role: Research Scientist
Keyskills:
Process CapabilityRoot Cause AnalysisManufacturing OperationsManufacturing ProcessProcess ValidationProcess QualityProcess Engineering
Desired Profile:
Education:UG -B.Pharma – Pharmacy
PG – M.Pharma – Pharmacy
Doctorate – Ph.D – Advertising/Mass Communication, Pharmacy
Company Profile:
Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses – Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Major therapeutic focus is on gastro-intestinal, cardiovascular, diabetology, oncology, pain management and anti-infective. Major markets include India, USA, Russia-CIS and Europe apart from other select geographies within Emerging Markets. For more information, log on to: www.drreddys.com
Contact Details
Recruiter Name:Venkat Vishwanath
Contact Company:Dr Reddys Laboratories Ltd
Telephone:Not Mentioned
Reference Id:TT- Sterile Injectables
Website:http://www.drreddys.com