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Team member-AQA
3 months ago
Accountable to overall analytical quality assurance activities in CTO-III.
1.2 Review of chemical & Chromatographic Data guiding the team towards GLP requirements & compliance.
1.3 Handling of Out of specifications & out of trend investigations related to QC.
1.4 Timely closure of investigation reports & incident reports and ensuring the timeline extensions.
1.5 Thorough review of electronic data like chromatographic integration & sample sets during the signoff-2 review.
1.6 Ensuring the CAPA closures related to QC Incidents, OOS & OOT.
1.7 Ensuring the QC related CCF's approval, review, verification & final closure.
1.8 Support during the Internal & external audits.
1.9 Guiding the team in technical issues during the analytical data review.
1.10 Review of complaints investigations related to quality control.
1.11 Review of analytical ROA's related to Incidents, OOS & OOT.
1.12 Review of investigations & closing before release of batches.
1.13 Electronic data verification of standalone system and chromatographic systems with respect to CDS and Non CDS checklist.
1.14 Giving usage decision of inspection lots related to Raw material, packing material Intermediate, Finished products in Caliber LIMS/SAP.
1.15 Review of Audit trails for all the instruments related to Quality control.
1.16 Review of all Raw materials, Intermediate, finished (API) and stability testing data for its
Correctness to fulfill the MOA and specification criteria.
1.17 Verification of ATR /COA/ ROA for its accuracy and to give usage decision.
1.18 Review & approve of Daily temperature monitoring printouts of QC laboratory.
1.19 Support to investigations of incidents and closing of incidents.
1.20 Monitoring of QC- lab activities inline with GLP, Lab compliance, standard Operating procedure, specification and method of analysis.
1.21 Handover of released batch ATR'S and BPR'S to archival.
Additional InformationAbout 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. he 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 catalyse 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. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we're always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.
For more details, please visit our career website at
