18331-QA Specialist-Meath Contractor

This is an 11-month contract initially.

Purpose:

• This role will be part of our Disposition SDWT in our state-of-the-art single-use multi-product biotech facility in Dunboyne, County Meath, Ireland.
• The QA Operations Specialist role involves supporting the operational activities, technical transfers, regulatory approvals, and commercial operations at the single-use multi-product biotech facility.
• The organizational structure at the site will be based on self-directed work teams where decisions will be made at the level where the data exists.
• The QA Operations Specialist will work across the site self-directed work teams and hub teams to identify and resolve issues to allow the site to deliver on our committed culture that supports Quality, EHS, Learning, and Continuous improvement.
• The QA Operations Specialist will be responsible for supporting the Operations team, ensuring compliance with cGMP and corporate regulations.

Responsibilities:

• Provide QA oversight to the qualification/validation, technical transfers, regulatory approvals, and commercial operations at the facility.
• Review/Approval of validation/Qualification/verification protocols and reports associated with new product or material entry.
• Helps maintain site practices and procedures related to facility start-up, instrument qualification, usage, technology transfer execution, and commercial manufacturing.
• Responsibility for adhering to domestic and international GMP regulations, cGMPs, company policies, leadership behaviors, and performance and budget management.
• Responsible for supporting the execution of an effective Quality System and accountable for quality oversight of quality management systems (CAPAs, Change Controls, Deviations Batch Documentation Review).
• Reviews and approves batch records, discrepancy reporting, investigations, and CAPAs associated with all areas of Manufacturing operations.
• Liaises with internal partners (e.g., Manufacturing Operations, Process development Technical services (PD-TS), Engineering functions, etc) in support of daily operations.
• Coordinate with peer Quality groups to ensure on-time disposition of commercial Drug Substances.
• Ensures clear communication on issues and timely escalation as applicable.
• Provide support and expertise for the preparation of regulatory submissions, and inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, and monitoring of follow-up actions.
• Champion site metrics to ensure targets are achieved and met and countermeasures in place when applicable,
• Provide QA oversight to the qualification/validation, technical transfers, regulatory approvals, and commercial operations at the facility.
• Review/Approval of validation/Qualification/verification protocols and reports associated with a new product or material entry.
• Helps maintain site practices and procedures related to facility start-up, instrument qualification, usage, technology transfer execution, and commercial manufacturing.
• Responsibility for adhering to domestic and international GMP regulations, cGMPs, company policies, leadership behaviors, and performance and budget management.
• Responsible for supporting the execution of an effective Quality System and accountable for quality oversight of quality management systems (CAPAs, Change Controls, Deviations Batch Documentation Review).
• Reviews and approves batch records, discrepancy reporting, investigations, and CAPAs associated with all areas of Manufacturing operations.
• Liaises with internal partners (e.g. Manufacturing Operations, Process development Technical services (PD-TS), Engineering functions etc) in support of daily operations.
• Coordinate with peer Quality groups to ensure on-time disposition of commercial Drug Substance.
• Ensures clear communication on issues and timely escalation as applicable.
• Provide support and expertise for the preparation of regulatory submissions, inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, and monitoring of follow up actions.
• Champion site metrics to ensure targets are achieved, met and counter measures in place when applicable,
• Representing Quality on multidisciplinary teams.
• Executing company policies.
• Ensures new/revised quality system requirements are deployed to the Site.
• Ensures execution leads for Quality-owned business processes are established who subsequently work with the business process owner to continually improve processes.
• Ability to work on his/her own initiative in addition to working as part of a team, and must be open to shift work. Must be able to work across a team matrix in order to meet accelerated timelines.

Requirements:

• Degree or post-graduate qualification in Science, Pharmacy, or equivalent.
• 4+ years experience in QA.
• Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site-level products & related processes.
• Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification, and validation activities; production & process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc.
• Demonstrated collaboration, negotiation & conflict resolution skills.
• Excellent communication skills (written and oral).
• Required to work on his/her own initiative in addition to working as part of a team and must be open to shift work. Must be able to work across a team matrix to meet accelerated timelines.
• Demonstrated understanding of continuous quality/process improvement tools (As defined by the site, e.g., DMAIC, Lean QA, 5S, etc).
• Experience in performing internal audits and participating in external audits.
• Exceptional analytical, problem-solving & root-cause analysis skills.
• Ability to multi-task and handle tasks with competing priorities effectively.
• Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators.
• Experience with working in a multinational organization.
• Strong operations support background ensuring value-added and effective quality oversight