Ensure the IT quality system are in compliance to the regulatory requirements
Support the creation and implementation of relevant IT quality procedures (SOPs)
Review and approve IT Validation plans, system assessments and schedules
Ensure IT system periodic reviews are performed
Manage IT QA projects (including new system implementation)
Provide input into business decisions in the assessment and specification of IT requirements
Provide support for the preparation of the requirement specification.
Ensure key system documentation consistently meets the required quality standards throughout its lifecycle
Coordinate operational change management / test activities to ensure ongoing compliance with business and regulatory requirements
Ensure IT quality processes and standards are aligned at the sites through collaboration with the Quality Assurance functions
Ensure resolution of identified quality exposures at site as well as in projects in a timely manner
Approve quality related lifecycle documentation.
Ensure the compliance with respect to the regulatory requirements at the site for the computerised systems
Other activities as may be required, at the discretion of management
Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Other
Employment Type: Permanent Job, Full Time
quality it QA IT CSV 21 CFR GAMP5 data intergrity EU Annex 11
Desired Candidate Profile
Education:UG -Any Graduate – Any Specialization, B.Sc – Any Specialization, B.Tech/B.E. – Any Specialization
Sun Pharmaceutical Industries Ltd
Sun Pharma an international,specialty pharmaceutical company headquartered in India with a global manufacturing network across 25 countries. We manufacture and market a large basket of pharmaceutical formulations as branded generics & generics in India, US and across the world. Our leadership is approachable, encourages transparency & strong work ethics to ensure that people get the best opportunities to learn and grow. We encourage our employees to challenge themselves for highest level of performance through greater bandwidth of work responsibilities and growth opportunities. Apply to us if you wish to be part of Sun Pharma growth story.