QA Compliance Auditor
Our client a global biopharmaceutical organisation are currently recruiting for a QA Compliance Auditor to join their global QA Audit & Compliance team. This is a permanent opportunity which can be based anywhere in Europe and will require the successful candidate to travel for up to 50% of the time.
• Provide constructive evaluation of quality related systems for suppliers that provide materials, services and products to the organisation. Suppliers can include API suppliers, contract labs, excipient suppliers, commodity suppliers, devices, specialty pharmacies, logistic providers and third-party manufacturers.
• Assess compliance of systems, facilities, and procedures per applicable regulations through audits and assessments of our suppliers, assuring compliance to regulatory requirements and specifications
• Provide feedback in the form of audit observations, and review corrective actions to determine if corrective actions and commitments have been properly implemented, proven to be effective and are being maintained at the supplier
• The position serves a tactical purpose for the organisation and must achieve a difficult balance of involvement and objectivity.
• Participate in strategic initiatives to improve compliance to regulatory requirements and standards
• Bachelor’s Degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering) or equivalent industry experience (at least 4 years) with sufficient exposure to pharmaceutical, medical device, or combination product related industries
• 2+ years in Quality Assurance with some project management experience in the pharmaceutical, medical device/nutritional or related industry. One year in compliance/auditing is required. Total combined experience expected to be at least 6 years
• Must have a technical background and requires understanding of the audit process and knowledge of worldwide requirements related to GMP regulations for quality systems and compliance
• Must understand a variety of quality/operational systems that support facility, product design, development, production, distribution, installation, support and service and understand the principles of quality management
• The individual must have excellent oral/written communications skills
• Personal skills needed include interpersonal skills, tact, open mindedness, maturity, tenacity, self-reliance, organizational/administrative skills and sound judgment. Effective communication skills are essential with an ability to work effectively outside of the company and across functional and technical areas
• ASQ certification desired, not required
• Fluent in English
If you would like further Information you can contact the recruiter directly:
Sinead Cullen | Tel: +353 (0) 1 507 9252