Executive Summary of the Role
The successful candidate will be responsible for the execution of development and trial batches aimed at troubleshooting, quality enhancement, and cost optimization. You will serve as a primary liaison with Contract Manufacturing Organizations (CMOs), managing technology transfers and ensuring robust process validation across various sites.
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Core Accountabilities
- Process Optimization & Reformulation: Lead the reformulation of existing products to enhance quality and cost-effectiveness while conducting extensive literature searches to guide experimental design.
- Technology Transfer & Validation: Coordinate site-to-site product transfers and ensure the rigorous documentation of feasibility and optimization batches.
- Risk Management: Evaluate and qualify alternate raw material sources to mitigate supply chain risks and ensure continuous compliance with established specifications.
- Stability Monitoring: Oversee the preparation and monitoring of stability batches for new and reformulated products, ensuring comprehensive data compilation.
- Regulatory Documentation: Prepare and review Master Formula Records (MFR), Batch Manufacturing Records (BMR), and Product Development Technical Reports in alignment with GMP and QMS requirements.
- Compliance Oversight: Monitor pharmacopeia updates and regulatory notifications, ensuring all standards are implemented within required timelines.
Professional Qualifications
- Academic Background: Bachelor’s or Master’s degree in Pharmacy (B.Pharm / M.Pharm).
- Experience: A minimum of 5-7 years of comprehensive experience across Product Development, Technology Transfer, and Quality Assurance.
- Technical Proficiency: Advanced knowledge of Pharmaceutical Technology, cGMP, Revised Schedule M, and Quality Management Systems.
- Soft Skills: Proven ability in troubleshooting and problem-solving, with an assertive communication style and a high level of attention to detail.
- CTC: Between 8.00-10.00 LPA
Organizational Synergy
This position requires effective cross-functional collaboration with Supply Chain, Marketing, and Regulatory authorities to align quality objectives with broader business goals.
