Team Member-aqa

6 months ago

Telangana, India Dr Reddy's Laboratories Limited Full time

**Company Description**
Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because **Good Health Can’t Wait**.

We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries.

For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity - to strengthen our core further (the next steps) and to build the future (the new bets).

‘The Next and the New’ is how we aim to continue to be the partner of choice - purpose-driven, future-ready and sustainable. Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose - helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency

Dr Reddy’s maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization.

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 Information** 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. 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 digital

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