Job Information
Sun Pharmaceuticals, Inc Sr Executive- IT Quality Compliance in India
Job Description
Position: Sr. Executive R&D Quality (QA-IT)
Grade:
No of Positions: 1 No.
Job Location: Vadodara
Job Responsibilities:
To ensure compliance of all GxP computerized systems as per Sun CS QMS and regulatory requirements.
Monitoring team progress and performance, identifying areas for improvement and implementing corrective actions as needed.
Perform GxP computerized systems assessment referring requirement of 21 CFR part 11, EU Annex 11, applicable regulatory standards, adequate security and controls
Timely communicate/discuss identified gaps to responsible team. Coordinate with relevant team for compliance/closure of the identified gaps.
Ensure remediation of identified gaps systems compliance in timely manner with the support of CFT team for continuous improvements.
Support sites to R&D labs for internal/ external audit observations.
Perform proactive assessment of regulatory and internal audit observations in both Vadodara and Gurugram sites.
Support gaps remediation programs, prioritized the remediation based on risk.
Perform periodic validation status review of computerized systems with the support of relevant stakeholders
Preparation and implementation of relevant quality procedures for computerized systems (SOPs).
Ensure alignment of sites SOPs related to Computerized Systems against global CSQMS
Support and effectiveness check of GQS/GSOPs implementation at sites
Provide support/guidance to remediate legacy/non-compliant computerized systems, to ensure compliance with applicable regulatory standards
Support for implementing the global Quality-IT initiatives at sites
Ensure availability of inventory of IT systems, infrastructure, CSVMP and its compliance with CSQMS
Ensure key documentation of computerized systems consistently meets required quality standards throughout its lifecycle
Perform other duties as assigned by Functional Head time to time.
Educational Qualification : B.Tech or BE Instrumentation/Electrical/Computer/E.C. Engineering / M. Sc with CSV experience.
Work Experience: 7 to 10 years of work experience.
CSV Experience, Knowledge of GAMP 5: Good Automated Manufacturing Practice Validation of Automated System in Pharmaceutical Manufacture, Guideline Version 5.0
21 CFR Part 11 Electronic Records, Electronic Signatures
GDP (Good Documented Practices) and GxP Compliance. Also well versedin Validator software
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.
Sun Pharmaceuticals, Inc
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