Manager / Lead Associate - Quality Audits

Company: Disability Solutions
Location: Princeton
Posted on: April 19, 2024

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 seeking a highly skilled and experienced Auditor to join our Compliance team and ensure that our operations meet all applicable pharmaceutical regulations and quality standards. As an Auditor (Lead Auditor) at Dr. Reddy's, you will play a pivotal role in maintaining and enhancing our commitment to regulatory compliance, quality assurance, and continuous improvement in pharmaceutical manufacturing. You will be responsible for planning, executing, and reporting on audits to ensure that our operations align with current Good Manufacturing Practices (cGMP) and other relevant pharmaceutical regulations. Key Responsibilities:

• Lead and conduct audits as assigned to ensure compliance with ICH Q7, 21 CFR Part 211, 21 CFR Part 111, ISO 9001:2015, and other applicable regulations and standards.
• Planning and conducting audits of vendors' quality management systems, manufacturing processes and facilities.
• Develop comprehensive audit plans, including scope, objectives and risk assessment.
• Conduct thorough assessments of potential vendors' quality systems, capabilities, and processes to ensure alignment with organizational quality standards.
• Conduct verification checks of corrective actions identified in audit responses, CAPAs, complaint responses, and other sources as assigned.
• Assessing and prioritizing high-risk areas within the organization and developing strategies to mitigate compliance risks.
• Prepare, revise, and execute vendor Quality Agreements
• Communicate audit results to senior management and regulatory authorities when necessary. These encompass core responsibilities of the Quality Manager Auditor, focusing on the planning and execution of audits, regulatory expertise, compliance management, and effective communication with internal and external stakeholders.Qualifications/Skills:
  • BS. or MS. in Chemistry, Biology or other life sciences is preferred.
  • Auditing Certification (e.g., Certified Pharmaceutical GMP Professional - CPGP) is a plus.
  • 7+ 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.
  • Excellent communication and interpersonal skills.
  • This role may require 20 to 30% travel domestically and internationally. 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. COVID-19 Vaccination Getting vaccinated remains the most effective way to halt the spread of the COVID-19 pandemic, and Dr. Reddy's encourages all employees to be vaccinated. At this time, vaccinations are not mandated for Princeton-based employees but may become required 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 , Manager / Lead Associate - Quality Audits, Executive , Princeton, New Jersey