Lead Associate Analytical Quality and Compliance

Dr. Reddy's Laboratories; Hyderabad; On-site; INR 60,000 - 80,000; Full time

Benefits offered by this job

Medical coverage

Relocation support

Family support (Maternity & Paternity benefits)

Learning and development opportunities

Job summary

Dr. Reddy's Laboratories is looking for a Lead Associate in Hyderabad. This role involves independent oversight of Analytical Quality and Compliance for Quality Control across North American sites, ensuring adherence to regulatory requirements.

The ideal candidate will have at least 7 years of experience in Quality Assurance or Quality Control within a regulated bio-pharmaceutical environment, as well as a relevant bachelor’s degree. The position offers benefits like medical coverage and professional development opportunities.

Qualifications

• 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 a Bio-Pharmaceutical regulated environment.
• Experience and working knowledge in Analytical R&D quality, quality control/QA and related quality systems.

Responsibilities

• Manage regional Internal & external laboratory audits.
• Provide analytical quality oversight for change management and control processes.
• Ensure effective data review across the North America region.

Skills

Quality Assurance/Quality Control experience

Analytical R&D quality knowledge

Data integrity

GMP Quality control

Knowledge of Quality Risk Management principles

Education

Bachelor’s degree in chemistry/microbiology or science

Job description

Job Description

North America business group seeks to hire Lead Associate, Analytical Quality and Compliance, based in Hyderabad office. The incumbent will provide independent oversight of Analytical Quality and Compliance for Quality Control across North American Internal and External sites in alignment with federal regulatory requirements. The role includes providing 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 markets.

Responsibilities

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 basis 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

Qualifications

• 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 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.

Benefits Offered

At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy include joining and relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, and life coverage for yourself.

Equal Employment Opportunity

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.

Our Work Culture

Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t 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 we’re 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 buoy 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.