Team Member

4 weeks ago

Andhra Pradesh, 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.
**Job Description** Job Summary**
We are seeking an individual for the Quality Assurance team, responsible for overseeing various Analytical quality assurance activities to ensure compliance with regulatory requirements and maintain product quality. Your responsibilities will include review and release of batches, compliance and audit readiness.

**Roles & Responsibilities**:
- Review and approval of SOPs, Spec & MoAs, Forms, Calibration reports, Qualification and protocols & reports in Dochub.
- Review and approval of analytical method transfers, Method validations & printed ROA’s.
- Providing the training as per the training schedule.
- Review, evaluation, coordination and approval of changes notifications.
- Ensure effective implementation of cGMP systems and procedures in Quality Control Laboratory.
- Participate in investigation of Incidents, OOS & OOT and provide CAPA.
- Review of qualification, maintenance and calibrations of equipment/ instrument are carried out as per schedule.
- Ensuring stability data to support retest or expiry period and storage condition on APIs and / or intermediates, where appropriate.
- Responsible to review & approval of stability protocols & reports.
- Review and usage decision of all materials & saleable intermediates after reviewing relevant documents in SAP.
- Quality review of retention samples.
- Review & usage decision for calibrations and qualifications (approval and rejection) in Labware LIMS.
- Electronic data management for laboratory instruments/systems.
- Review of Bio-burden testing of API.
- Review and approval of Microbiology procedures, Microbiology equipment’s/instruments qualifications, BET, MLT tests and Validations protocols and reports.
- Review of the data /approval process of the primary E-Records for chromatographic and non
- chromatographic testing including the audit trails to ensure that all testing on such systems is documented, reported and reviewed.
- Monitoring & Review of audit trail for Laboratory instruments as per the schedule.
- Usage decision of RM/KSM/PM/API/ Intermediate after reviewing relevant documents in SAP / LIMS

**Qualifications**
**Educational qualification**:A Bachelor’s/ Masters degree in Pharmacy, Chemistry.

**Minimum work experience**: 3 to 7 years of experience in pharmaceutical manufacturing or a similar role

**Skills & attributes**:
***
**Technical Skills**
- Good knowledge on Empower software, Labware LIMS.
- Skilled in reviewing Analytical raw data.

**Behavioural Skills**
- Attention to detail in performing line clearance, verification, and record reviews.
- Communicates effectively with team members and stakeholders regarding batch-related activities and compliance.
- Applies problem-solving skills in addressing issues related to line clearance, sampling, and record certification.
- Demonstrates a focus on maintaining high-quality standards and adhering to regulatory compliances in analytical methodology.

**Additional Information** About the Department**
**Global Manufacturi

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