Dr Reddy's Laboratories Limited
Pharma
LeadAssociateAnalyticalQualityandCompliance
“Lead Associate Analytical Quality and Compliance at Dr Reddy's Laboratories Limited. Skills: Analytical Quality, Quality Compliance, Laboratory audits, Regulatory requirements. Provide oversight of Analytical Quality. Provide oversight of Compliance for Quality Control”
What You'll Achieve.
Ensure reliable supply of products; Ensure consistent quality of products
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 and support
Ensure effective use of procedures
Assure compliance of GXP processes
Manage laboratory audits
Manage supplier quality
Manage analytical change
Manage change control
Manage stability program
Conduct laboratory GAP assessments
Provide laboratory compliance expertise
Provide analytical quality oversight
Provide quality leadership
Provide oversight for nitrosamine risk
Provide oversight for testing strategies
Provide oversight for method validation
Provide oversight for method verification
Provide oversight for regulatory commitments
Provide quality oversight of APQRs
Provide quality oversight of PQRs
Ensure laboratory trends assessed
Ensure OOS/OOT events assessed
Ensure method performance assessed
Ensure stability data assessed
Ensure investigation outcomes assessed
Identify laboratory risks
Identify 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
Ensure OOT/OOS management
Ensure risk escalation
Provide guidance for product robustness
Deploy training of procedures
Ensure data review controls
Support resolution of issues
Support during 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
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