Lead Associate - Quality Assurance

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 a Lead Associate Quality Assurance for Middleburgh plant (On Site) to provide support for all Quality Assurance activities. The incumbent will work closely with the Site Quality Head to ensure all aspects of the site operations are conducted using cGMP methodology as well as follow 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.
• Manage process for review of artwork and specification changes for labelling.
• Assesses compliance aspects of computer systems, such as Empower.
• Maintains thorough working knowledge of compliance requirements and policies, regulatory agency developments, and industry trends.
• Manages site response to questions regarding regulatory filings from any regulatory agencies.
• Manages daily Product Assurance functions including batch record review and release of finished goods to stock.
• Drafts, or approves deviations and non-conformance reports as appropriate.
• Manages training/education function, including development and administration of training activities relating to cGMPs and company policies, including development of in-house programs, maintaining audio/visual information, and maintaining training records.
• Manages documentation control function, including preparation and distribution of plant SOPs, maintenance of historical files, master batch production records, and issuance of procedures.
• Develop and execute an overall plan for conducting audits that will provide for the identification and resolution of any deviations from GMP and applicable QMS requirements.

Provides audited areas with support and guidance to achieve corrective and preventive actions.

• Maintain a follow-up corrective and preventive action (CAPA) system to ensure required improvement and programs are implemented as planned.
• Assists with management of product surveillance program (i.e., product complaint response program and trending).
• Captures and ensures appropriate mitigation of compliance risks identified internally and externally via risk management procedure/process. Logs identified risks and assists with the development/approval/communication of appropriate risk mitigation plans (CAPAs). Maintains documentation.
• Prepares, reviews, and revises pertinent plant SOPs.
• Assists with maintaining the Approved Vendor List for DRL NY Inc. suppliers of inventory items.

Qualifications

Educational qualification: BS in Chemistry, Pharmacy, Biological Sciences, or related field.

Minimum work experience:  Minimum 10-12 years of Pharmaceutical/QA experience.

Skills & attributes:

• Strong knowledge of FDA regulations, cGMP, and labelling requirements.
• Knowledge of CFR and pharmacopoeial requirements.
• Knowledge of audit processes related to the FDA and other regulatory agencies.
• Management skills.
• Analytical thinking and technical knowledge.
• Auditing skills and experience.
• Strong knowledge of USP (and any other relevant compendia) requirements.
• Strong knowledge of validation concepts.

*Must be a U.S. citizen or lawful permanent resident of U.S. or otherwise authorized to work in the U.S. without