Lead Associate - Analytical Quality and Compliance

We are looking for a Lead Associate, Analytical Quality and Compliance in our Quality function. This role will provide an independent oversight of Analytical Quality and compliance for Quality Control Laboratories across North American Internal and External sites in alignment with federal regulatory requirements; 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 Compliance in the Laboratory including Audit Readiness and risk management to ensure reliable supply of consistent quality of pharmaceutical products in the US and Canada market.

Responsibilities:

• Manage and provide quality oversight for Analytical quality control projects and support to ensure compliance to the organizational and regulatory standards.
• Support the Quality system, which includes supporting the management and Quality Assurance review and/or approval of OOS, Change Controls, Deviations, and associated CAPA.
• Assist in Regional Internal & External Laboratory Audits, Supplier Quality Management. Conduct Laboratory GAP Assessments and provide Laboratory Compliance Expertise.
• Provide guidance for product robustness, deploy training of regional quality control procedures in collaboration with Business unit quality groups.
• Support in resolution of analytical problems at other Dr. Reddy’s internal sites within North America.

Educational qualification: A minimum of a bachelor's degree (chemistry/ microbiology, or science) is required

Minimum work experience: 10+ years of experience in a Quality Control/Quality Assurance role in pharmaceuticals manufacturing and testing

Skills & attributes:

• 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.
• Experience in working with external manufacturers and testing labs.

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 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.   Equal Opportunity Employer An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability.

For more details, please visit our career website at https://careers.drreddys.com/#!/