Job Information
Sun Pharmaceuticals, Inc Lead - Quality IT (CSV) in India
Job Responsibilities:
Perform review of Computerized System Validation of IT systems of Manufacturing Sites
Support various phases of Computer System including Planning, Implementation, Maintenance and retirement activities by ensuring compliance with internal / external regulatory requirements
Perform GxP computerized systems assessment referring requirement of 21 CFR part 11, EU Annex 11, applicable regulatory standards, adequate security and controls
Support sites for audit readiness with respect to CS validation, electronic data management and to comply an internal/ external audit observation
Ensure key documentation of computerized systems consistently meets required quality standards throughout its lifecycle
Perform periodic validation status review of computerized systems with the support of relevant stakeholders
Provide support/guidance to remediate legacy/non-compliant computerized systems, to ensure compliance with applicable regulatory standards
Perform assessment of vendors whenever new Vendor is introduced in organization to assure vendors Quality Systems are effective and meet standards
Timely communicate/discuss identified gaps to responsible team. Coordinate with relevant team for compliance/closure of the identified gaps
Support projects/initiatives for simplification, harmonization and productivity enhancement
Mentor and provide support in the education and training of personnel in relevant areas of compliance and validation for GxP IT systems.
Perform other duties as assigned by Functional Head time to time.
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.