Lead Associate Analytical Quality and Compliance

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 datadriven and inspectionready
• 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. Reddys Laboratories sites as needed including support during regulatory inspections and for-cause investigations

Qualifications :

A minimum of a bachelors 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.

Additional Information :

Benefits Offered
At Dr. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddys are on par with the best industry standards. They include among other things and other essential equipment joining & relocation support family support (Maternity & Paternity benefits) learning and development opportunities medical coverage for yourself and your family life coverage for yourself.

Our Work Culture
Ask any employee at Dr. Reddys why they come to work every day and theyll say because Good Health Cant Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations but as a means to help patients lead healthier lives and were always attuned to the new and the next to empower people to stay fit. And to do this we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system they can make magic.
For more details please visit our career website at Work :

No

Employment Type :

Full-time

Experience: years
Vacancy: 1