Handles instrument calibration, environmental monitoring, sampling, and analysis of raw materials, in-process samples, & finished products. Maintains records, controls samples, prepares reagents, follows SOPs, & supports team duties as needed. Required Candidate profile A detail-oriented QC professional skilled in instrument calibration, environmental monitoring, sampling, & analysis of raw materials, in-process samples, & finished products, SOP compliance.
Responsible for carrying out batch charging & processing activities as per BMR, operating & cleaning production equipment in compliance with SOPs and cGMP standards, & verifying raw materials for accuracy & traceability. Required Candidate profile A disciplined production professional with API experience, strong in batch processing, equipment handling, GMP compliance, safety, documentation, & teamwork. High-potency API experience is a plus.
Process Review & Improvement: Periodically review the process/identify areas for improvement to achieve market competitiveness. Troubleshooting: Identify the root cause of OOS & provide robust CAPA Address unplanned deviations of the Plant with the Solutions. New Product Development: Develop new products in the stipulated timeline as per cGMP requirements. Alternate vendor development: Undertake alternate vendor development to improve the product quality and reduce raw material cost. Pilot & technology Transfer: Scale up laboratory batches in the Pilot plant & establish feasibility. Ensure that development is implemented by Process & Technology transfer. Ensure the Process is robust, safe & validated. Collaboration & Communication: Interdepartmental Collaboration: Work closely with other departments to ensure that PDL's initiatives align with the organisation's broader goals. Timely reporting of issues with proposed solution presentation, and data-based reports Training & Development: Team Development: Invest in training programs to upskill the PDL team, Production team and foster a culture of continuous learning. Knowledge Sharing: Promote a culture where team members share insights and knowledge, ensuring collective growth and innovation.