Title:  Sr Executive- IT Quality Compliance

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 System’s 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 versed in Validator software