SME - Computer System Validation (Quality-CSV)

• Performing audits of all Dr. Reddy’s Laboratories manufacturing, packing, testing, development centers and distribution warehouses as per the audit schedule.
• Primarily performing internal audits of CTO, FTO and R&D Sites.
• Performing GAP assessment of the new/revised regulatory guidance documents, USFDA warning letters / form 483s to evaluate the current approved documents for compliance / improvements or requirement of new procedures and harmonizing and implementing the best practices across sites.
• Review of audit responses and tracking the CAPA generated out of internal audits, regulatory audits, customer audits, cross-applicable CAPAs through OCMS, Warning letters & 483 forms gap assessment of all sites for timely and effective implementation. Performing on site verification or review of the documented evidence for compliance of previous audit observations.
• Preparation and review of harmonized Standard Operating Procedures and Guidance documents which shall be implemented at Global, FTOs, CTOs business units and related supporting functions. Assessing the impact on the procedures during implementation of changes in IT applications.
• Overview harmonization of CSV/IT compliance practices across Dr Reddy’s sites.
• Ensuring timely assessment and implementation of pharmacopeia and regulatory guidance updates w.r.t. CSV/IT compliance procedures across Dr Reddy’s sites.
• Ensuring review and implementation of simplification procedure for different CSV/IT compliance procedures across Dr Reddy’s sites to reduce redundancy.
• Tracking and revision of SOPs identified during SuCCEED drive and Re-Imagine QMS.
• Conducting training sessions for the approved documents before implementation of the procedure.
• Preparation of questionnaire for SOP in order to evaluate the effectiveness of training imparted.
• Initiation and review of quality notifications raised for revision, preparation of documents as per identified requirements.
• Timely communication to stakeholders about revision/implementation of SOPs.
• Providing data for monthly report.
• Providing support to sites during regulatory audits for review of systems / documents.
• Any work assigned by the Lead and Head of the Department

M.Sc (Chemistry) with 15+ years of Pharma experience in IT/CSV quality

About the Department

Global Manufacturing Organisation (GMO)