Senior Manager/Assistant Director - Lifescience Audit Lead - Delivery Excellence

An urgent opportunity for a Lifescience Audit lead with a leading IT MNC for Chennai/Pune Location.

JOB DESCRIPTION - LS Validation audit

Exp: 11+ Years

Level: SM / AD

BU- s: Delivery Excellence

Location: Chennai/ Pune

Role: Lifescience Audit lead

Role:

An audit lead who can guide and drive a team of qualified auditors for the life sciences engagements across business services like AD, AVM, BPS, EAS etc., The role would involve planning and conducting of audits and other interventions in the engagements and reporting the action items to the BU leadership and DE leadership at appropriate intervals with the objective of driving the BU towards higher levels of delivery and process maturity. Accountable for performing the above as per organizational processes and SLAs applicable from time to time.

Experience and skills :

- Strong knowledge and experience of LS domain, GXP, GAMP, CFR 21, validation / regulation requirement and SDLC

- Exposure to quality framework/methodology such as ISO, CMMI, ISO 13485 (for medical devices) etc.,

- Experience in preparing / readiness assessment of engagements and the BU for health authority inspections, customer and third party audits, CAPA management

- Sufficient delivery background would be an added advantage

- Clear articulation and communication skills required for interacting at appropriate levels - with senior delivery personnel, BU leadership, customer POCs etc., as per business need