NPI QA Specialist

Summary

Summary: An NPI QA Specialist is required for a biopharmaceutical company is West Dublin. The successful candidate will be responsible for delivery of quality assurance activities onsite to ensure new products are introduced and manufactured in accordance with cGMP, corporate and regulatory requirements.

Responsibilities

• Quality Oversight on new product introduction in a bulk drug substance facility.
• Site QA responsibility to provide technical expertise for all QA and compliance topics / issues relating to the manufacturing facility.
• Review and approve project documents involving cross-functional, multi-departmental teams including: operations, process engineering, quality control, quality assurance, facilities, and others.
• Review and approval of validation documents for equipment, software and equipment qualifications, and others. (e.g. URS, Facility, Utility, IT Systems, Test Method, and Equipment validations) to ensure compliance with current regulatory expectations, EU, FDA and Corporate Standards and Internal Procedures.
• Quality oversight on operations and technical services to review and approve Process descriptions, sampling plans, operational procedures, process validation and cleaning validation documents.
• Review and approve TRA's, MSRs, SAP requests related to new products.
• Ensure all materials are sampled and released as per the approved specifications and procedures.
• Investigation and approval of deviations generated encountered during qualification/validation testing.
• Participation in the project change control program and deviations for modifications to new and existing equipment.
• Provide guidance to project teams on quality regulations for validation strategy and approach.
• Performs timely review of documentation/investigations/reports highlighting and assisting in the resolution of issues commensurate with the level of risk
• Ensures schedules for review and approval of GMP documents are maintained to meet the needs of commercial operations groups.
• Provide sound QA and Compliance support to manufacturing, engineering, utilities, supply chain and material movement.
• Provide support for deviation investigations, including root cause analysis, and corrective & preventative action (CAPAs) proposals and initiatives.
• Actively support audit readiness activities and regulatory agency and internal audits.

Qualifications & Experience

• Third level qualification e.g. B.Sc. in science/pharmacy.
• A minimum of 5 years relevant experience within the pharma industry or a related field.
• Strong knowledge of cGMP requirements for pharmaceutical manufacturing and/or packaging 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/EMA or other authorities of similar standing.
• Good knowledge of relevant computer packages e.g. Delta-V, Veeva vault 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.