Job Opportunity: Executive / Sr. Executive – Formulation Development (Orals)
Job Summary
As a member of the Product Robustness Review and Compliance Team, you will be responsible for assessing product robustness, reviewing technical documents for various markets, participating in harmonization activities, and ensuring compliance with regulatory standards. This role requires strong document management skills and a solid understanding of formulation development, statistics, statistical tools, and regulatory guidelines.
Areas of Responsibility
- Technical Document Review: Evaluate the adequacy, raw data, and quality of technical documents within defined service level agreements (SLAs) for regulated markets.
- Product Robustness Assessment: Conduct thorough assessments to ensure product robustness.
- Statistical Analysis: Perform and review statistical assessments using tools such as JMP and Minitab for probability assessments (S1/S2), shelf life extrapolation, inverse extrapolation, and Design of Experiments (DOE).
- SOPs and Guidelines: Prepare, revise, and review internal and harmonized Standard Operating Procedures (SOPs) and guidelines.
- Document Management:
- Provide document numbering and maintain records as per SOP/guidelines.
- Manage the issuance, archival, and retrieval of documents and laboratory notebooks (LNBs).
- Oversee inventory management for LNBs.
- Share historical data from the database with the team as needed.
- EDAMS Archival: Manage and provide inputs for Laserfiche scanning of documents for the Electronic Document and Archive Management System (EDAMS).
- Training: Conduct “Train the Trainer” activities.
- Quality Management System (QMS): Participate in QMS-related activities using the TrackWise system.
- EDMS Support: Provide support for the Electronic Document Management System (EDMS).
Additional Information
- Experience: 2 to 5 years
- Qualification: M.Pharm
- Location: Tandalja – R&D
- Industry Type: Pharma/Healthcare/Clinical Research
- Functional Area: Formulation Orals
- Application End Date: 20th June 2024
Join our team and contribute to the advancement of pharmaceutical formulations through rigorous assessment and compliance practices. Apply by 20th June 2024 to become part of a leading organization in the healthcare industry.
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