PSC Biotech is looking for a QA Validation Specialist to support the quality oversight of validation activities in a cGMP regulated environment.
Contract
This is a 12‑month contract role with the possibility of extension. Applicants must be eligible to work full‑time in Ireland (EU, UK or Stamp 4 visa holders).
Overview
A high level of initiative, energy and motivation are key role requirements, as well as strong organisational skills.
The position is responsible for supporting the quality oversight of validation activities in a GMP regulated environment, incorporating implementation, requalification and decommissioning of manufacturing processes, equipment, computer systems, laboratory systems and changes to existing equipment.
Responsibilities
Key Subject Matter Expert (SME) and Quality Oversight representative in specific validation discipline(s).
Maintains current knowledge of industry standards and regulatory requirements for validation techniques/approaches utilised.
Supports the QA Validation group in maintaining regulatory compliance, in line with industry best‑practices in specific validation discipline(s).
Supports complex investigations, regulatory submissions, specific regulatory queries and agency inspections in SME areas of expertise.
Supports strategy development and ensures regulatory compliance for validation projects; strategically supports complex validation projects across a variety of disciplines.
Provides mentorship and SME support to more junior members of the QA Validation team and cross‑functional groups as applicable.
Leads and represents QA Validation in multi‑departmental meetings and project teams.
Identifies and leads implementation of improvements to validation systems.
Quality Oversight for Validation execution activities related to the various validation disciplines, including supporting and reviewing/approving validation lifecycle documentation (e.g., URS, Risk Assessments, Commissioning Documents, Qualification Protocols, Re‑validation/Periodic Review Reports).
Supports development of validation plans for specific system implementation projects.
Establishes site validation policies through development, generation and implementation of site validation master plans, guideline documents and standard operating procedures.
Provides Quality Oversight for any assigned change requests, deviations, quality events and associated CAPAs. Other duties as assigned.
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 demonstrated knowledge of facility, equipment, utility, process, lab systems and CSV validation.
Organisational 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 and European regulatory requirements, guidelines and recommendations for equipment validation expectations.
Proficiency with technical summary report generation required, with exceptional organisational, spelling, grammar and typing skills preferred.
Contacts
This position will require interaction with multiple levels (from technicians up through senior management) in Engineering, Quality Assurance, Quality Control, Corporate Compliance, Manufacturing, Manufacturing Sciences, Facilities, Regulatory Affairs, Accounting and Human Resources.
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