Dr. Reddys Laboratories Ltd. 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. Reddys offer a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars, and differentiated formulations.
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The major therapeutic focus is on gastrointestinal, 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
Position: MSAT Associate – Upstream with Biologics
Location: Hyderabad, Telangana, India
Purpose of Job:
- Participate in Scale-up of the process from Pilot Plant/ R & D to the manufacturing facility in close coordination with Pilot plant/R & D and Manufacturing team
- Identify and highlight scale-up issues/Post-scale-up issues and suggest remedial measures before tech transfer
- Responsible for review of development report and acceptance of process from Pilot plant
- Responsible for successful scale-up of processes and its troubleshooting where ever needed
- Responsible for ensuring manufacturability of the process from point of view of process robustness, material availability, and costing
- Lead investigation for deviations using various available tools like RCA, Fishbone analysis, etc.
- Provide strategic directions in investigating deviations, out of trend and Out of specification to suggests a robust CAPA
- Use tools to identify CPPs and CQAs to improve the process robustness and yield
- Participate in Process Characterization and preparation/review of Process Validation protocol/report
- Participate in continuous process verification of the commercial process on regular basis using available tools and prepare required documents for the same.
- Provide technical inputs for Facility and Layout design, equipment selection
- Co-ordinate effectively across teams to resolve a complex issue and drive new initiatives with a concerted effort
- Participate in investigating any customer complaint from a technical point of view
- Implement the use of new technologies depending on the latest industry updates and best practices
Roles & Responsibilities:
Process scale-up From R& D / Pilot to manufacturing facility
- Monitoring lab batches,
- Scale-up studies,
- Safety & effluent data generation etc. Process scale-up studies in R&D lab through Necessary protocols/reports.
- Making material balance and quality mapping at lab scale
Manufacturing process support
- Participate actively in major and critical deviations investigation.
- Support for the right CAPA identification and involvement in the implementation
- Troubleshoot at manufacturing unit operation and perform additional studies if required.
Preparation of safety & Quality documentations:
- Implement Documentation Practices as per the company’s quality policy; ensure that compliance (regulatory, statutory, and legal) are understood,
- Ensuring the team for preparation of all PSM documentation, supporting documents for trail & validation, technical closure reports, etc.
- Ensuring the preparation of Technical justifications, closure reports, Investigation reports, etc.
Continuous Process Verification
1. Conduct CPV for the products in the manufacturing facility on regular basis.
2. Investigation of OOS/ OOT
3. Ensure the process is within control limits
Implementation of New Technologies:
- Assess new technology for the available products which is more efficient operationally and cost-effective
Qualification: MTech/MSc in Bioprocess Technology/ Biotechnology / with Masters/Bachelor’s Degree in Chemical Engineering
Experience: 3+ years of post-qualification experience in API or Pharma industry in new technologies and PAT tools area. Any experience in operational excellence and Six Sigma methodology will be an added advantage.
Salary: 4,00,000 TO 8,00,000 INR CTC/PA
Mr. Naresh Kumar – Talent Acquisition
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