Senior Auditor (Pharmaceutical Contract Manufacturing) - PureTek Corporation

The Senior Auditor is responsible for planning, executing, and reporting on audits of internal processes, systems, and external suppliers (contract manufacturers, packagers, testing labs, etc.) to ensure compliance with current Good Manufacturing Practices (cGMP), relevant regulations (e.g., 21 CFR Part 210/211), and company quality standards. This role is critical in identifying and mitigating risks to product quality, safety, and efficacy.

Essential Duties and Responsibilities:

1. Audit Planning and Execution:
   Develop and execute risk-based audit plans for internal processes and external suppliers.
   Conduct audits in accordance with established procedures, ensuring objectivity and independence.
   Evaluate the effectiveness of quality systems and identify areas for improvement.
   Document audit findings clearly and concisely.
2. Audit Reporting:
   Prepare comprehensive audit reports detailing observations, deviations, and recommended corrective actions.
   Present audit findings to relevant stakeholders, including management and auditees.
   Track and verify the implementation of corrective and preventive actions (CAPAs).
3. Regulatory Compliance:
   Maintain up-to-date knowledge of relevant regulations (e.g., cGMP, 21 CFR) and industry standards.
   Provide guidance and support to ensure compliance with regulatory requirements.
   Participate in regulatory inspections as needed.
4. Continuous Improvement:
   Identify opportunities to improve audit processes and methodologies.
   Contribute to the development and maintenance of quality systems and procedures.
   Collaborate with cross-functional teams to address quality issues and improve overall quality performance.
5. Supplier Management:
   Participate in supplier qualification and selection activities.
   Monitor supplier performance and compliance through regular audits and reviews.
   Facilitate effective communication and collaboration with suppliers to address quality issues.
   

Qualifications:
Education: Bachelor's degree in a scientific or technical discipline (e.g., pharmacy, chemistry, biology,engineering).

Experience:
Minimum of 5 years of experience in quality assurance or auditing roles within the pharmaceutical industry,with a focus on contract manufacturing.
Proven track record of conducting successful audits and driving quality improvements.
Strong knowledge of cGMP regulations (21 CFR Part 210/211) and other relevant standards.

Certifications: 

ASQ Certified Quality Auditor (CQA) or equivalent certification preferred.

Skills:
Senior Auditor (Pharmaceutical Contract Manufacturing)