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Pharmaceutical Compliance Partners, LLC (PCP) is a boutique management consultancy focused on delivering value to our customers through management consulting, assessments, strategy, and operations consulting within the Regulatory Affairs, Quality Assurance and Commercial Compliance disciplines of the pharmaceutical / biotech industry. PCP largely operates through a non-exclusive network of contractors and consultants. We are seeking independent contractors/consultants to fill a variety of projects in 2021.

**** Calling All Auditors ****

PCP is actively seeking qualified auditors to conduct pharmaceutical and/or biotech GXP audits in 2021. We also have opportunities for audit related activities (development of audit plans, checklists, report templates, CAPA reviews, etc.)

We are particularly interested in auditors with experience conducting audits of: CROs, TMFs, investigator sites, central laboratories, bioanalytical laboratories, clinical manufacturing/packaging sites, GLP laboratories (in vitro & in vivo), vaccine manufacturing, sterile manufacturing, environmental controls. cold chain distribution, GXP quality systems, data integrity, data management and IT systems used to support clinical trials (CTMS, SAS, IW/RT, eTMF, etc.).

Required Experience and Qualifications

• BA/BS degree in a scientific discipline
• 5+ years of GXP audit experience
• Detailed knowledge of FDA, EU, UK, and ICH governmental regulatory guidelines, directives, regulations related and industry best practices for pharmaceuticals and/or biologics
• Expertise in Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Distribution Practices (GDP) and/or Good Pharmacovigilance Practice (GPVP)
• Expert in effective quality management systems
• Experience as a solo auditor or lead auditor and comfortable conducting solo audits
• Experience working effectively with cross-functional teams in a fast-paced, dynamic environment
• Strong attention to detail
• Excellent interpersonal, verbal, and written communication skills
• Comfortable in a fast-paced small company environment with minimal direction
• Superb organizational skills and an ability to deliver results within established timelines
• Evidence of recent training in their GXP function
• MS Word, Excel, and PowerPoint proficiency
• Based in the US or Canada

Preferred Experience and Qualifications

• MA/MS or doctoral degree in a scientific discipline
• 10+ years of GXP audit experience
• 15+ years of industry experience
• Auditor certification
• Experience conducting remote/virtual audits
• Mastery of more than one GXP
• Detailed knowledge of governmental regulatory guidelines, directives and regulations related to pharmaceuticals and/or biologics beyond FDA, EU, UK, and ICH
• Experience evaluating audit responses
• Experience evaluating the appropriateness and effectiveness of CAPAs
• Vendor qualification and due diligence expertise

Nice-to-have Experience and Qualifications

• HCT/gene therapy experience
• Combination product experience
• Parenteral / sterile product experience
• Cold chain experience
• Medical device experience

Apply on LinkedIn  https://lnkd.in/dt8GF5w