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 equipments 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.

Qualifications :

Educational Qualification

A Bachelors or Masters 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

Additional Information :

About the Department

Global Manufacturing Organisation (GMO)
At Dr. Reddys 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 1150 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. Reddys we actively help to catalyze your career growth and professional development through personalised learning programs.

The benefits you will enjoy at Dr. Reddys 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. Reddys why they come to work every day and theyll say because Good Health Cant Wait. This is our credo as well as the guiding principle behind all our actions...

For more details please visit our career website at Work :

No

Employment Type :

Full-time