This is a remote contract role.
Responsible for delivery of quality assurance activities at the site’s Athlone fill finish facility to ensure commercial and/or clinical products are manufactured in accordance with cGMP, Corporate and Regulatory requirements.
• Provide technical expertise for all QA and compliance topics / issues relating to the company’s manufacturing and product supply of drug product.
• Acts as quality point person, providing guidance and feedback on quality assurance issues.
• Ensures schedules for review and approval of GMP documents are maintained to meet the needs of Clinical and Commercial Operations groups.
• Provide support for deviation investigations, including root cause analysis, and corrective & preventative action (CAPAs) proposals and initiatives.
• Administer the change control, deviation and CAPA systems on site.
• Deliver Quality Assurance review and approval of SOPs, master batch records, policies, operational standards, validation protocols and reports as required.
• Actively contributes to continuous improvement activities.
• Represent QA during regulatory inspections.
• A minimum of 7-10 years relevant experience within the pharma industry or a related field.
• 3-5 years’ experience in a QA environment in a leadership role.
• QP Qualified is desirable.
• Strong knowledge of cGMP requirements for pharmaceutical manufacturing required. Experience of sterility assurance for drug products and in manufacturing processes for pharmaceutical products and processes strongly desirable.
• Direct experience of GMP management within a pharma/biopharma company is essential, and will include exposure to FDA, HPRA or other authorities of similar standing.
• Excellent accuracy and attention to detail.
• Good knowledge of relevant computer packages e.g. Trackwise or similar.
• Planning and organizing skills are required to plan, execute and track commitments of Quality Assurance and to adjust to changing priorities.
• High level technical skills including analytical, auditing, pharmaceutical manufacturing and regulatory inspection management.
• Technical writing skills required.
• Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written.
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