Qa Validation Specialist

3 days ago

Cork, Cork, Ireland Pm Group Full time

Overview The Outsourced Technical Services (OTS) Department at PM Group partners with Global leaders across a range of industries to find the best people for their current and ongoing business needs.
Partnering with PM Group and our clients means that you will gain unrivalled experience working with global brands.
We are seeking a skilled and experienced QA Validation Specialist to join a Client Validation team.
This role will be 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.
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 by the client, validation techniques/approaches and systems utilized at the client site 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.
Qualifications Bachelor of Sciences degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required +5 years' experience in a cGMP regulated manufacturing environment, with knowledge of equipment and utility validation, and laboratory systems / validation Organizational and management skills to coordinate multi-discipline project group 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.
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