Dr Reddy's Laboratories Limited
Pharma
LeadAssociateAnalyticalQualityandCompliance
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“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.
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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