North America business group seeks to hire Lead Associate, Analytical Quality and Compliance, based in Hyderabad office, the incumbent will provide an independent oversight of Analytical Quality and Compliance for Quality Control across North American Internal and External sites in alignment with federal regulatory requirements. You will provide direction, support and guidance to ensure effective use of Analytical Quality Control procedures, policies and systems, assuring compliance and Improvement of key GXP processes, audit readiness and risk management to ensure reliable supply of consistent quality of pharmaceutical products in the US and Canada market.
Responsibility:
Manage regional Internal & external laboratory audits, supplier quality management, analytical change management, change control process, and the stability program. Conduct laboratory GAP assessments and provide laboratory compliance expertise.
- Provide analytical quality oversight for analytical change management and laboratory change control processes
- Provide quality leadership for analytical quality control projects and base business support to ensure compliance with the organizational and regulatory standards
- Provide oversight for nitrosamine risk assessment, analytical testing strategies, method validation/verification, and regulatory commitments, in alignment with FDA and Health Canada expectations
- Provide quality oversight and review of Annual Product Quality Reviews (APQRs/PQRs) from an analytical and laboratory compliance perspective
- Ensure laboratory trends, OOS/OOT events, method performance, stability data, and investigation outcomes are appropriately assessed, justified, and documented within APQRs
- Identify systemic laboratory and analytical risks through APQR trending and ensure linkage to CAPA and continuous improvement initiatives
- Review and approve laboratory investigations (OOS, OOT, deviations, atypical results), ensuring root cause analyses are scientifically sound, data-driven, and inspection-ready
- Ensure effective data review and data integrity controls across the North America region with timely resolution of findings and observations
- Support regulatory response strategies related to laboratory investigations and data integrity observations
- Ensure effective governance of the stability program, including protocol compliance, trending, OOT/OOS management, and risk escalation
- Provide guidance for product robustness, deploy training of regional quality control procedures in collaboration with Business unit quality groups
- Ensure Data review controls across North America region including inspection readiness and resolutions
- Support resolution of analytical, laboratory, and compliance issues at other Dr. Reddy's Laboratories sites, as needed, including support during regulatory inspections and for-cause investigations
. A minimum of a bachelor's degree (chemistry/ microbiology, or science) is required.
. 7+ years of experience in a Quality Assurance/Quality Control role in 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.
