Gmp Auditor

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PharmaLex is a highly successful and growing consulting company for the Healthcare industry. PharmaLex offers professional development, training, competitive compensation, plus a stimulating and collaborative work environment. We are committed in providing exciting career opportunities in an atmosphere that values trust, respect, teamwork, creative talent, enthusiasm and diligence.
General Description:
We are seeking consultants who can provide support as a GMP Auditor in the pharmaceutical and biotechnology industry.
Responsibilities:

• Conduct and manage quality, compliance, and auditing activities to provide assurances that operational activities are conducted in compliance with applicable regulations, guidelines and the company’s policies and standards.
• Support contracted audits to verify compliance.
• SME to assist with facilitation of audits in preparations for and participate in regulatory authority inspections.
• Hosts external audits/inspections e.g. regulatory inspections, strategic clients. Assists with the facilitation of audit responses.
• Provide consultation and compliance advice for the organization and support a quality framework that protects patient safety and assures regulatory compliance.
• Interpretation of regulations and guidelines, searches of published information and interactions with other QA and regulatory professionals.
• Support compliance projects such as management of quality issues, CAPA projects, or other Quality Assurance and cross-functional initiatives.
• Delivery of training in performance of audits (basic, intermediate, complex).

Requirements:

• A minimum of a Bachelor’s Degree in a Pharmacy, Chemistry or Biology related discipline.
• Postgraduate degree (MSC or equivalent) in science or management related discipline, preferable.
• 10 years industry experience on a GMP regulated facility
• With lead auditor certification is preferred
• Experience of industry quality systems/standards.
  • US Regulations: 21 CFR 4, 11, 210, 211, 600, 610, 820
  • EU Regulations: Eudralex Volume 4, Chapters 1-9, Part II, Annex 1, Annex 2, Annex 11, Annex 15, Annex 16, Annex 19
  • Applicable national and international management system standards (e.g., ISO 9001, ISO 14644, ISO 17025, etc.
  • National and international industry guidelines, standards and current industry practices (e.g., ISO, WHO, USP, EP, JP, GAMP, etc.)
• Excellent interpersonal/organizational skills, e.g. communication, decision making, negotiating, problem solving.
• Able to influence QA strategy systems/standards and ability to apply appropriate regulatory knowledge to multiple scenarios.

PharmaLex is an Equal Opportunity Employer.
 

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