GSK - Site Validation Lead

Job description :

Site Name: India - Maharashtra - Nashik Site

Responsibilities :

Management, co-ordination and execution of all types of Validations (Process, Equipment, Cleaning, CSV, etc) and related activities & documentation at Nashik site as per local Regulatory and GSK QMS requirements.

Any Additional Information : CSV and PLM capability required as per current standards

Educational Qualifications : B.E. / M.E.

Years of Experience : Minimum 10 years

Type of Experience :

- Pharmaceuticals (Secondary Manufacturing)

- Exposure to audits from highly regulated markets

Key Skills :

- Pharmaceutical Validations and Qualifications, PLM, CSV.

- Self-driven with end-to-end understanding - right from Change Control, equipment and process understanding to completion and execution of validation.

Justification :

- This is a key role which manages all types of validations and qualifications at site, which in turn is a key element of PLM. Validated and qualified equipment and manufacturing process are required by regulatory and GSK QMS as a pre-requisite to commercial manufacturing. Hence, there is a risk of non-compliance to regulatory and GSK QMS guidelines and also to continue commercial manufacturing if this role is not perfomed.

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.

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