Lead Associate - Quality Audits

Company: Disability Solutions
Location: Princeton
Posted on: September 21, 2023

Job 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. Purpose We are looking for a seasoned Quality Compliance professional who will provide assessment on company sites, internal GMP departments, external partners, and quality systems for ensuring compliance with regulatory requirements and expectations, standards, industry trends, and regulatory commitments as well per company policies and procedures. Incumbent will support readiness for regulatory inspection and will collaborate across the regional organization to participate in cGMP and GDP compliance initiatives and continuous improvement. The role will report to Lead, Quality & Compliance. Responsibilities :

• Maintain and enhance the Supplier management process using quantitative methods to identify high-risk suppliers
• Conduct detailed assessments of manufacturing processes, quality control procedures, and documentation systems to ensure compliance with established standard
• Identify areas for process improvement and recommend corrective actions to enhance efficiency and quality outcomes
• Conduct audits of external suppliers and vendors to assess their adherence to quality standards
• Prepare comprehensive audit reports detailing findings, observations, and recommendations for improvement
• Drive the implementation of quality improvement initiatives based on audit findings and industry advancements
• Conduct thorough assessments of potential vendors' quality systems, capabilities, and processes to ensure alignment with organizational quality standards
• Plan and execute audits of vendors' quality management systems, manufacturing processes, and facilities to ensure compliance with relevant regulations and industry standards
• Regularly monitor and analyze vendor performance data to identify trends and potential issues
• Communicate quality expectations and vendor-related updates to internal stakeholders, ensuring alignment and understanding across the organization
• Maintain Regional Supplier Qualification Reports & Audit Reports
• Prepare and manage Approved Vendor
• Support regulatory compliance oversight of Dr. Reddy's North America business and identify areas for correction to eliminate compliance gaps
• Proactively research new and upcoming regulations and guidelines
• Supports the Regional Quality Council and Coordinates compliance metrics for North America and provides periodic updates to Executive Management
• Prepare, revise, and execute quality agreements with all vendors in the quality system Qualification / Skills:
  • S. or M.S. in Chemistry, Biology or other life sciences is preferred. Auditing Certification is preferred
  • 8+ years of progressive experience in auditing pharmaceutical or medical device systems, this experience should include 2 years of internal and external audit management
  • Strong understanding of pharmaceutical, combination product or medical device manufacturing, packaging and testing processes, and management of Quality Management Systems
  • Thorough understanding and familiarity with auditing, GMP regulations, including 21 CFR 210, 211, 111, 820, ICH guidelines, IPEC guidelines, FDA guidance documents
  • Required to travel domestically and internationally
  • Excellent verbal and written communication skills, organizational and time management skills; strong attention to detail
  • Strong writing skills as a result of producing technical documents such as Standard Operating Procedures, Summaries, investigation reports, audit reports, and technical change control.
  • Understanding of QMS in pharmaceutical manufacturing and packaging facilities and excipients manufacturers 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.Equal Opportunity Employer: 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.

Keywords: Disability Solutions, Trenton , Lead Associate - Quality Audits, Accounting, Auditing , Princeton, New Jersey