Lead Associate Analytical Quality and Compliance
On-site · Hyderabad, Telangana, India
Job Summary
Lead Associate, Analytical Quality and Compliance based in Hyderabad, responsible for independent oversight of Analytical Quality and Compliance for Quality Control across North American internal and external sites. Provides direction and guidance to ensure effective use of analytical quality control procedures, policies, and systems, assuring compliance, and improving key GXP processes with audit readiness and risk management to ensure reliable supply of pharmaceutical products in the US and Canada. Key duties include managing regional internal & external laboratory audits, supplier quality management, analytical change management, change control, and the stability program; conducting GAP assessments; providing oversight for nitrosamine risk assessment, method validation/verification, APQRs/PQRs; ensuring data review and data integrity controls; supporting regulatory response strategies and inspections; governance of the stability program; and training regional quality control procedures.
Required Qualifications
- Minimum of a bachelor's degree (chemistry, microbiology, or science)
- 7+ years of experience in a Quality Assurance/Quality Control role in a Bio-Pharmaceutical regulated environment
- Experience and working knowledge in Analytical R&D quality, quality control/QA and related quality systems
- Supervisory experience and sound knowledge of Quality Control, data integrity and data review experience
- Proven record in support of GMP Quality control and Analytical R&D quality
- Knowledge of Quality Risk Management principles
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