Senior Executive - Quality Assurance - Pharma

The role is in Stability Operations department, responsible for the management of stability testing of pharmaceutical products and active pharmaceutical ingredients manufactured in the different manufacturing sites worldwide in a highly regulated environment.

Education : Bachelor of Pharmacy (B. Pharm)/ Master of Pharmacy (M. Pharm) or any equivalent advanced degree.

Experience : 7-8 years of experience in Manufacturing and Quality Assurance with a minimum 5-6 years of core QA experience.

People Management : None

Location : Mumbai ( Only Mumbai candidates apply)

Job Responsibilities :

- Good understanding of regulatory guidelines (21 CFR, Eudralex, ICH, Indian D&C Act), correct interpretation and implementation of the same in actual practice.

- Quality assessment of non-compliance trends, identification of training needs, and designs appropriate courses/solutions to address those needs.

- Quality systems knowledge like Handling of Deviations and Quality investigations, Change controls, CAPA, Trainings, Internal audits.

- Review and Approval of GMP documents, SOPs, Work instructions, protocols.

- Should be able to write SOP's related to Quality Operations independently.

- Provide training to shop floor personnel in manufacturing unit.

- Review of Batch Manufacturing and Batch Packing Record and handling of Batch release activities independently.

- Compiling of Quality metrics data and performing trend analysis.

- Stability process, Method development and Validations, Method transfer, Cleaning validation, Equipment qualification and verification and life cycle management,Computerized system validation, Risk Assessment, Purified system validation, Environmental monitoring, Microbiology

Candidates with Pharma experience only apply.

Niketa