Date PostedMarch 21, 2023
Location (State / UT)
Experience5 Years, 7 Years
Desired QualificationMaster’s Degree
Executive R&D Quality – (Commercial QA and QMS)
Roles and Responsibilities:
- To assist in developing procedures / Quality systems and assure compliance of the same by identifying gaps through document review and Audits.
- To review and approve QMS documents for cGxP compliance and centralized QA oversight for GMP Laboratories.
- Review documents, approve discrepancy notes, and handle quality activities of the Medicinal Product Store to ensure compliance with cGMP requirements.
- Review / Author SOPs for the compliance of the cGMP requirements and monitoring its implementation.
- Ensure the periodic activities as per the quality procedures are performed in a timely manner.
- Review and monitor In-vitro BABE study to ensure compliance with regulatory requirements and established procedures.
- 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 Process Quality Lead (PQL) for Validation of computerized system.
- Review and approve of inventory of computerized systems and infrastructure, at the site and ensure its compliance status.
- Author / review the site Computerized System Validation Master Plan (CSVMP) as per the quality procedure.
- To review and approve external sample analysis reports.
- Review and Approve validation deliverables and lifecycle documentation for the computerized system as a Process Quality Lead.
- Review and approve System release and retirement documents as per the quality procedures.
- Ensure the availability of the site CSVMP as per the quality procedure.
- Perform the GxP computerized systems assessment and ensure 21 CFR part 11, EU Annex 11 readiness, adequate security, and controls.
- Mentoring and supporting site cross-functions to resolve issues.
- To assess the compliance level of all the GxP departments through the Self Inspection / Internal Audit program. To support all-time readiness for successful regulatory inspection at R&D.
- Lead the assessment, tracking of remediation, and monitoring of identified actions as part of various Corporate initiatives.
- Present/discuss and define the way forward for fast-track remediation of open action items in site QRB meetings.
- Perform other duties as assigned by the Functional Head from time to time.
Qualification: M.Pharma, MS/M.Sc(Science)
Experience: 5-7 Years