The person would be responsible for supporting the upkeep of the QMS.
Support in making changes to the QMS and working with function heads to coordinate process creation, template creations and updates to existing processes/templates.
Support in rolling out Trainings with regard to Processes
Drive, Track and close Non-Conformances raised across delivery groups as an outcome to process audits.
Follow-ups on audit outcomes and support in necessary documentation and connecting with action owners to drive closures
Coordinate and participate in the external audits/assessments.
Be accountable for reviewing and supporting key CSV deliverables – URS, Validation Plan, Test Plan,
Traceability Matrix, Test Summary Report and Validation Summary Reports.
Reviewing of the Qualification scripts (IQ, OQ, PQ scripts, results and reports) deliverables for
Quick learner with positive attitude
Software engineering discipline
Knowledge of GxP, QA best practices and regulatory guidelines
Experienced in Documentation authoring and requirement analysis (min. 3 years)
Can interpret business requirements to technical/ application requirements and vis-a- versa
Experienced in Process engineering (desirable)
Experience with electronic document management system is a plus.
Well-organized and detailed oriented professional, with strong verbal and written communication skills.
Must be self- motivated with ability to handle, organize and prioritize multiple tasks and be able to perform under pressure to meet deadlines.
Proven ability to identify quality issues/discrepancies and effectively and proactively resolve the issues/discrepancies in a diplomatic, flexible and constructive manner. Additional Qualifications
BE/B.Tech/MCA from recognized institute with good academic score.
Quality professional with 4 years of hands-on experience with document control process in bio