Quality Validation Expert

Role: Quality Validation Expert

- Location: Peenya, Bangalore

- Experience: 812 years

Must-Have Skills:

- Strong knowledge of validation and ISPE guidelines.

- Experience with QMS and handling equipment and process validation.

- Mandatory pharmaceutical industry background.

Job Description:

As a Quality Validation Expert, you will identify, plan, and implement validation requirements in a cGMP environment. This includes overseeing cleanrooms, equipment, instruments, and manufacturing/testing processes in a Green Field Pharma facility. You will be responsible for preparing and executing IQ/OQ/PQ protocols, coordinating computer system validation, and ensuring compliance with all applicable standards.

Candidate Requirements:

- Education: Master of Science (Life Science) from a reputed institution.

- Experience: Minimum of 8 years total experience, with at least 5 years specifically in Quality Assurance within reputed pharmaceutical industries or research institutes.

Key Responsibilities:

- Develop and maintain the Validation Master Plan (VMP).

- Conduct risk assessments and ensure compliance with cGMP, GAMP 5, and FDA regulations.

- Collaborate with Quality, Production, Engineering, and IT teams to drive validation and quality assurance deliverables.

- Participate in internal and external audits and respond to validation-related findings.