Dr Reddy's Laboratories Limited

Pharma

LeadAssociateAnalyticalQualityandCompliance

₹19–28L ~AI est. Hyderabad, Telangana, India FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for entry candidates.

The Brief

“Lead Associate Analytical Quality and Compliance at Dr Reddy's Laboratories Limited. Skills: Analytical Quality, Quality Compliance, Laboratory Compliance, Regulatory Requirements. Provide oversight of Analytical Quality. Provide oversight of Compliance for Quality Control”

What You'll Achieve.

Ensure reliable supply of consistent quality; Assure compliance and Improvement of key GXP processes; Ensure audit readiness

Industry & Context.

Pharma
Problems you'll solve

Root cause analysis; Risk assessment; Troubleshooting

What They're Looking For.

Must Have

Bachelor's degree required, 7+ years QA/QC experience, Experience in Analytical R&D quality, Experience in quality control/QA, Experience in related quality systems, Supervisory experience required, Knowledge of Quality Risk Management

Nice to Have

Master's degree preferred, Experience with FDA, Experience with Health Canada

What You'll Do.

Provide oversight of Analytical Quality

Provide oversight of Compliance for Quality Control

Provide direction for Analytical Quality Control procedures

Provide support for Analytical Quality Control policies

Provide guidance for Analytical Quality Control systems

Assure compliance of GXP processes

Manage regional laboratory audits

Manage supplier quality

Manage analytical change management

Manage change control process

Manage stability program

Conduct laboratory GAP assessments

Provide laboratory compliance expertise

Provide analytical quality oversight

Provide quality leadership for projects

Provide oversight for nitrosamine risk assessment

Provide oversight for analytical testing strategies

Provide oversight for method validation

Provide oversight for method verification

Provide oversight for regulatory commitments

Provide quality oversight of APQRs/PQRs

Ensure laboratory trends are assessed

Ensure OOS/OOT events are assessed

Ensure method performance is assessed

Ensure stability data is assessed

Ensure investigation outcomes are assessed

Identify systemic laboratory risks

Identify systemic analytical risks

Ensure linkage to CAPA

Ensure linkage to continuous improvement

Review laboratory investigations

Approve laboratory investigations

Ensure root cause analyses are sound

Ensure root cause analyses are data-driven

Ensure root cause analyses are inspection-ready

Ensure effective data review

Ensure data integrity controls

Support regulatory response strategies

Ensure effective governance of stability program

Ensure protocol compliance

Manage OOT/OOS management

Manage risk escalation

Provide guidance for product robustness

Deploy training of QC procedures

Ensure data review controls

Support resolution of compliance issues

Support regulatory inspections

Support for-cause investigations

How You'll Work.

Team & Collaboration

Quality Control teams; Business unit quality groups; Cross-functional teams

Process & Methodology

Change control, Risk management

Full Job 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. North America business group seeks to hire Lead Associate, Analytical Qua

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