Team Member - QA Validation

Roles & Responsibilities

• 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.

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Educational Qualification

A Bachelor's or Master's degree in Pharmacy,

Minimum Work Experience

5 to 10 years of experience in a pharmaceutical or related industry with a focus on investigations and quality assurance

About the Department

Global Manufacturing Organisation (GMO)
At Dr. Reddy's Laboratories, we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we are a leading force in the pharmaceutical industry.

We operate 19 state-of-the-art manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, comprising 8 OSD facilities, 3 Injectables facilities, and 8 API facilities. Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1,150+ drug master files across key therapy areas such as Oncology, Cardio-vascular, Central Nervous System and Anti-Diabetes. The World Economic Forum has recognised our largest manufacturing facility in Bachupally, Hyderabad, as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive, meeting business imperatives, and meeting our ambitious ESG goals. Building such ‘factories of the future’ is integral to innovation and to build healthcare of the future.

" Benefits Offered

At Dr. Reddy’s we actively help to catalyze your career growth and professional development through personalised learning programs.

The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself.

" Our Work Culture

Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions...

For more details, please visit our career website at https://careers.drreddys.com/#!/

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