QA Validation Associate

4 weeks ago

Cork, Cork, Ireland Claran Consultants Ltd Full time

QA Validation Associate required for a high-performing Biotech facility in Ringaskiddy, Cork, responsible for the review and approval of validation lifecycle activities in a GMP regulated environment, focused on implementation of new manufacturing processes, equipment, computer systems, laboratory systems and changes to existing equipment. Initially a 12 month contract. RESPONSIBILITIES Provide project management oversight from a Quality perspective for FUE activities related to products and facilities, utilities, equipment (FUE). Assist Functional Validation groups in the development of validation plans for specific system implementation projects. Review and Approval of project lifecycle documentation (URS, RA, Commissioning, Qualification Protocols) validation activities related to the implementation of facilities, utilities, equipment changes while exercising judgment within broadly defined procedures and practices to establish approval criteria, and identify and implement solutions. Establish Site Validation Policies, through development, generation and implementation of validation master plans, guideline documents and SOP's. Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured, validation techniques/approaches and systems utilized at the facility Lead and represent Validation in multi-departmental meetings & project teams. Identify and implement improvements to the QA Validation systems. Participation in the change control program for NPIs, capital projects and modifications to qualified systems. Ensure maintenance of the qualified/validated state within the Revalidation Evaluation and Requalification programmes. Review and Approval of validation activities and documentation related to maintenance of qualified / validated states. Assess the impact of changes to the validated state of systems/equipment as part of the site change control program (e.g. system implementation projects /system modifications, etc.) and QMS deviations. Demonstrate a robust understanding of Change Control process, appreciating wider implications to site beyond immediate requirement. Identify, track and resolve issues through robust root cause analysis in a timely manner working with relevant SMEs as required. Apply a risk management approach to identify, categorise, prioritise, mitigate and establish contingency plans associated with qualification / validation and system risks Coordinate validation activities involving cross-functional, multi-departmental teams including: Engineering, Manufacturing, Process Sciences, Quality Control, Quality Assurance, Regulatory Affairs, and others. EDUCATION Bachelor of Sciences degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required. EXPERIENCE +5 years' experience in a cGMP regulated manufacturing environment, with knowledge of equipment and utility validation, and laboratory systems / validation. Experience with QA Oversight of Project activities QA Oversight / Execution of HVAC / Utilities qualification QA Oversight / Execution of Computer Systems Validation with focus on Data Integrity Organizational and management skills to coordinate multi-discipline project groups Ability to speak, present data, and defend approaches in front of audiences and inspectors. Ability to comprehend technical information related to equipment, processes, and regulatory expectations. Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections. Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for equipment validation expectations. Proficiency with technical summary report review and approval required, with exceptional organizational, spelling, grammar, and typing skills preferred. This position will require interaction with multiple levels (from technicians up through Sr. Management) in Engineering, Quality Assurance, Quality Control, Corporate Compliance, Manufacturing, Manufacturing Sciences, Facilities, Regulatory Affairs, Accounting, and Human Resources. Skills: QA Validation Project Validation Equipment Validation

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