Dr. Reddy’s Laboratories Ltd

Job Description

 We are seeking a skilled professional to serve as a specialist in upstream/downstream operations, specializing in processes and Process Engineering aspects in Sterile injectables. The role involves authoring validation protocols, conducting risk assessments, utilizing tools for process verification, and actively participating in technology transfers to ensure compliant, efficient, and continuously improved manufacturing processes.

Roles & Responsibilities

• Assess the knowledge transfer and absorb the knowledge from the transferring sites.
• Understand and Establish the required documentation from the technical perview of the process for the equipment through URS for complex products.
• Evaluate the capabilities of the equipment along with the site layout for placing the complex equipment
• Perform the FMEA of the Complex equipment from an end to end (Product initiation to Commercialization)  along with involvement of the FS. FDS, SDS, SAT activities and FAT activities.
• Trouble shoot the Equipment challenges from Scale-up to Process validation stages involving Lyos, HPH, ILHM, Filling lines, Compounding vessels, Isolators.
•  Preparation, review and approval of New product introduction Change controls, Technical Protocols, Reports and Product impact assessments related to Process validation.
• Include in the identification of the Root cause analysis for any OOT / OOS of the Products introduced at sterile facilities till Process validation.
• Support for Regulatory filings and Compliance issues for Sterile injectable products.
• Support for Regulatory audits.
• Absorb and transfer the products from the transferring site to FTO-11 and other sterile facilities with Pro-active approaches and risk mitigation strategies.
• Monitoring and support for scale up, manufacturing of process validation batches and first commercial batch for site-to-site transfer injectable product and new products from IPDO (as required).
• Provide support for trouble shooting, root cause analysis, and product impact assessments for nonconformance (incidents, OOS, OOT & Market complaint) investigation and process changes/ improvements.
• Preparation, review and Approval of Operational and process SOP.
• Initiation, review and Approval of change control and Risk assessments with respect to Validation and qualification activities
• Co-ordination with CFTs (i.e., Production, QA, QC) for Exhibits and Process Validation batches and BMR activity and various documentation.
• Preparation and review of Cleaning Validation and process related documents (Protocols, Reports, Master Plan and Assessments etc.)
• Preparation and review of CPV schedule and reports.
• Review of Product Quality reports (PQR’s).
• Training of employees.
• Serve as the fill finish process as subject matter expert.
• To perform any other task/project assigned by reporting authority.

Qualifications

Educational qualification: Master in Pharmacy (M.Pharm) or Master in Sciences (M.Sc) or Master’s (M.Tech. or M.Sc.) or a Ph.D.