Dr.Reddys Laboratories
Designation : Team Member
Function : Quality Assurance
Functional Area : QA Validation
Job Role Summary : Facility and Equipment Qualification – Review of Protocols and Reports, VMP Compliance, Review of Audit Trials, Sterile Process Validations
Job Profile :
- Review of qualification protocols and reports of facility, area, equipment, and utilities including URS, DQ/FS, RA, SLIA, Project specific qualification plan, commissioning checklist, IQ, OQ, UTM, PQ & RQ.
- Review and approval of smoke study protocol & report.
- Review of VMP and their subsequent revisions.
- Review of VMP re-qualification calendar for all equipment, facility, Utility etc.
- Review of PMP check list/schedules and Master calibration and Facility maintenance planner etc.
- Review of Audit trails, master instruments calibration certificates.
- Review of logbooks for its compliance and good documentation practices.
- Ensuring compliance to VMP revalidation schedule as per revalidation matrix for all equipment, facility, utility etc.
- Allotment of numbering for equipment’s, area, layouts and to prepare / Update the List.
- Handling and closure of quality management system which includes change controls, incidents & CAPA.
- Participation in investigations that are triggered due to incidents/deviations as applicable.
- Responsible for preparation, review of SOP as per requirement.
- Review of BMS & EMS related documents and alarms & audit trials reports for its compliance.
- Review of activity related to critical equipment breakdown notification.
- Review of equipment breakdown and general maintenance notification.
- Compilation and Preparation of Annual review of utilities reports.
- To perform GEMBA walk in utility system i.e. HVAC, compressed air, and water system, etc.
- Review of Pure steam quality reports, compressed air and nitrogen gas testing reports.
- Review of documents in DocHub, e-VAL, SAP DocuSign as applicable.
- Review of cleaning validation protocols and reports.
Job Requirements :
- 5 to 10 years of experience in a pharmaceutical or related industry with a focus on investigations and quality assurance
- Experience in Validations, Qualifications of Systems, Processes, Sterity Assurance
Work / Job Experience : 5-10 Years
Type of Experience : Pharma QA, Sterile Process Validation, Facilities Qualification
Academic Qualifications :
- A Bachelor's or Master's degree in Pharmacy,
