Lead Associate Quality Assurance

Description

At Dr. Reddy’s, a global pharmaceutical company, 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.

Job Duties And Responsibilities:

Serves as the quality leader within the Shreveport facility in the development and implementation of systems and procedures to effect compliance with applicable federal regulations and to ensure fitness for use of Dr. Reddy’s products in accord with customer expectations.

• • Direct and, through supervisory personal, in-direct day to day management of employees in the Quality department.
    • Oversees supervisors responsible for batch inspection, stability, and testing operations for the analytical and microbiological assessment of incoming, in-process, and finished products.
    • Administers program to review batch records, investigate manufacturing problems, and determine the material dispositions of components, in-process materials and finished products in conformance with quality standards.
    • Serves as a focal person for the control of changes in materials, processes, products, analytical methods and utilities. Works with Technical Support and Production to ensure proper validation, stability, and documentation requirements have been planned in order to implement the change.
    • Oversees Document Center for the facility. Approves masters, SOPs and ensures systems and processes are documented and reviewed on a periodic frequency.
    • Approver of GMP documents including but not limited to:
    • QC incident (deviation), OOT and OOS investigation reports.
    • Incident and complaints investigation reports.
    • Change Control document.
    • Qualification/Validation protocols and reports for facility systems and laboratory equipment.

  • Other responsibilities as requested by the site headConducts and documents root cause investigations for customer product quality complaints in accordance with industry guidance(s) and SOPs.

Key Personnel Attributes & Qualifications

• B.S. or M.S. in a Chemistry, Biology, or other life science is preferred
• 9-10 years of experience managing quality systems or directly associated with analytical and/or manufacturing quality in pharmaceutical dosage form facilities
• Experience managing quality events such as change controls, investigations, CAPA, documentation and training
• Experience in preparation and execution of GMP regulatory inspections
• Thorough understanding and familiarity with GMP regulations, including 21 CFR 210, 211 requirements, ICH and FDA guidance documents
• Excellent attention to detail, and ability to consistently meet high standards of quality required in QA Compliance
• Excellent verbal and written communication skills, organizational and time management skills
• Ability to work with internal and external manufacturing sites in a matrix environment
• Experience in setting clear and concise objectives and leading motivating teams
• Proficient with computer skills, statistical applications and SAP experience is preferred.
• Must be able to work occasional overtime and shifts per the needs of the business.

Equal Opportunity Employer: Minorities/Women/Veterans/Disabled

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