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, Levittown , Manager / Lead Associate - Quality Audits, Executive , Princeton, Pennsylvania
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