Team Leader - QA Validations

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.

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.

Job Responsibilities

Review and approval of qualification documents of facility, area, equipment and utilities i.e. URS, DQ, IQ, OQ, PQ & RQ etc.

1.2 Review and approval of VMP revalidation schedule, Calibration schedule, PMP schedules and facility maintenance schedules and ensure to its compliance.

1.3 Review and approval of PMP task list for equipment and instruments.

1.4 Review and approval of layouts for facility, utility, equipment etc.

1.5 Review & approval of airflow visualization study (smoke study) protocol & report.

1.6 Review of Validation Master Plan (VMP) and project specific qualification plan.

1.7 Review and approval of BMS & EMS related documents.

1.8 Review of activity related to critical equipment breakdown notification.

1.9 To participate and review of investigations for its appropriateness.

1.10 Review and approval of QMS elements like change control, Incident etc.

1.11 Review and approval of SOP’s / protocols / reports.

1.12 Review and approval of Quality Risk Assessment documents.

1.13 To Co-ordinate and participate in any internal /external /regulatory audits.

1.14 To ensure compliance of Audit observations if any.

1.15 Review and approval of cleaning validation documents.

1.16 Review and approval of computer system validation (CSV) documents.

MSC , M Pharmacy , B Pharmacy

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