Lead Associate / Manager Quality Control

Company Description At Dr. Reddy's 'Good Health Can't Wait' By joining Dr. Reddy's, you will contribute to making the breakthroughs of tomorrow a reality today From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready to inspire, ready to make a difference for their community and every community. Diversity, Equity & Inclusion At Dr. Reddy's, we are deeply committed to building a diverse, equitable and inclusive workplace where everyone belongs and is valued for their contributions to the team. We are most interested in finding the best candidate for the role and are open to exploring candidates with a less traditional background. Job Description Job Summary We are looking for Manager / Lead Associate Quality Control to provide support to the Middleburgh site in all Quality Assurance activities. The incumbent will work closely with site Quality Head to maintain all aspects of the site operations are conducted using cGMP methodology as well as follows all current regulatory guidelines. Responsibilities: Responsible for supporting management of the Quality System with a focus on continuous improvement and responsibility for ensuring compliance with cGMP, FDA requirements, and internal SOPs. Manage Reserve sample programs while adhering to internal procedures. Ensure that Annual Product Reviews, SOPs, Change Controls, Complaints, Investigations, CAPAs, Stability Management, IQ/OQ/PQ protocols and reports, and validation protocols and reports are managed in compliance with regulatory requirements. Ensures all quality stream documents (change controls, deviations, investigations, etc.) are completed thoroughly and by the required due date. Provide general QA Operations support to site activities with focus on documentation review, generation and approval. Conduct batch record review and release, change control review and approval, process and analytical investigations, Annual Product Reviews, CAPA follow up etc. related to products manufactured at CPOs to ensure compliance. Provide guidance to Quality Associates. Provides data in a timely manner as requested to other departments. Assists Site Quality Head during audits and inspections. Be continually aware of current industry trends and regulatory agency interpretation of cGMP requirements. Responsible to address issues and identify trends that help to ensure compliance, and development and implementation of process improvements. Ensures data integrity procedures are in place and effective. Conduct internal audits. Qualifications Educational qualification: BS or MS in Science with Pharmacy or Chemistry as major Minimum work experience: 7 years of experience Skills & attributes: Experience in GMP (Good Manufacturing Practice) in the pharmaceutical or medical device industry. Understanding and familiarity with GMP regulations, including 21 CFR 210 and 211, ICH guidelines, FDA (Food and Drug Administration) guidance documents. Must be a U.S. citizen or lawful permanent resident of U.S. or otherwise authorized to work in the U.S. without requiring sponsorship now or in the future. Additional Information 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

Created: 2024-11-02