Executive / Senior Executive- Development Quality Assurance (Pharma Business)

• Ensure Quality Assurance oversight for new product development, reformulation, technology transfer, scale-up, exhibit, and validation batches.

• Review and approve development-related documents including SOPs, specifications, protocols, analytical methods, batch records, validation reports, stability protocols, and reports.

• Coordinate and monitor Change Controls, Deviations, Incidents, CAPA, Risk Assessments, and Investigation activities related to product development.

• Perform in-process quality monitoring and compliance checks during formulation development, pilot trials, exhibit batches, and technology transfer activities.

• Review and evaluate analytical testing data, stability study results, method validation/verification reports, and development reports to ensure compliance with quality requirements.

• Coordinate new product quality testing activities with R&D, Quality Control, Production, and Regulatory Affairs to support timely product development and submission.

• Ensure compliance with cGMP, GLP, Data Integrity, WHO, USFDA, PIC/S, ICH, DGDA, and other applicable regulatory requirements throughout the product development lifecycle.

• Conduct internal audits, compliance reviews, and quality risk assessments within Development and R&D functions and ensure timely closure of observations.

• Maintain effective document control and ensure proper archival, issuance, and retention of development and quality records.

• Support regulatory inspections, customer audits, dossier preparation, product registration activities, and successful commercialization of new products.

Experience in Development QA, R&D QA, QA, QC, or Product Development of any pharmaceutical company.

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