Sun Pharmaceutical Industries, Inc. Hiring For Executive CMC QA at Vadodara, Gujarat Full Time

To ensure the compliance requirements of Quality Agreements / Contract Testing Agreements at R&D (Review, Management, Maintenance and other quality related activities).

To provide support for computerised systems to be implemented into R&D and to ensure the compliance of the same. Review and approve of computer system validation documents and other related documents as per CSQMS GSOPs.

To assist in developing procedures / quality system and assure compliance of the same by identifying gap through document review and Audits.

To review QMS documents for cGxP compliance and centralised QA oversight for GMP Laboratories (GxP Sections).

To review documents, approve discrepancy note and handle quality activities of Medicinal Product Store to ensure the compliance of cGMP requirements.

Review / Prepare SOPs for the compliance of the cGMP requirements and monitoring its implementation.

Review, Monitoring and managing In-vitro BABE study to ensure compliance as per regulatory requirements and established procedure.

Responsible to ensure GxP Computerized Systems at GxP laboratories, are in compliance with the current regulatory standards.

Ensure implementation of relevant quality policies, standards and procedures for computerized systems

Act as QA-lead for Validation of computerized system.

To review and approve external sample analysis reports.

Ensure key documentation of computerized systems consistently meets the required quality standards throughout its lifecycle.

Review and Approve validation deliverables and lifecycle documentation for computerized systems.

Ensure the availability of the site CSVMP as per the quality procedure.

Ensure the availability of inventory of computerized systems and infrastructure, and ensure its compliance status.

Ensure the periodic activities as per the quality procedures are performed in a timely manner.

Provide support in the education and training of personnel in relevant areas of compliance and validation for computerized systems.

Review and approval of QMS (Deviations, Change Control, CAPA, incidences, investigations etc.) related to computerized systems.

Ensure resolution of identified risks/gaps related to computerized systems in a timely manner.

Mentoring and supporting site cross functions to resolve issues related to computerized systems.

Perform assessment /audit of suppliers / vendors of site computerized systems.

Perform the GxP computerized systems assessment and support remediation for ensuring 21 CFR part 11, EU Annex 11 readiness, adequate security and controls.

Work in partnership with the site cross functions and corporate functions for “Audit readiness” of computerized systems (for Validation and lifecycle management) for all internal/external and regulatory inspections.

Draft response and comply internal/ external audit observations for computerized systems.

Lead the assessment, tracking of remediation and monitoring of identified actions as part of various Corporate initiatives.

Lead to present/discuss and define way forward for fast track remediation of open action items related to computerized systems in site QRB meetings.

To assess the compliance level of the all the GxP departments through Self Inspection / Internal Audit program. To support all time readiness for successful regulatory inspection at R&D.

Perform other duties as assigned by Functional Head time to time.