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Job ID: JOB-13251

Quality & Validation Manager

Location: Limerick

4 days on site per week

Interested in working within the largest Bio-pharma facility in Ireland? Our Limerick based Bio–pharmaceutical Client are seeking an Associate Quality Assurance & Validation Manager to join their team on a permanent basis.

This position implements policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards and oversees a team of Validation Specialists.

Key Responsibilities

• Manage, develop and build a team of subject matter experts in the areas of cleaning validation and SIP validation and continuing validation.
• Day to day management of resources, planning and assigning work to Validations Specialists and/or contingent workers to meet goals and deadlines.
• Ability to lead multiple and sophisticated validation programs, provide status reports and coordinating with other departments or outside contractors/vendors to complete validation tasks.
• Lead technical and quality investigations.
• Collaborates with functional departments to resolve issues.
• Manage a cross-functional project with many stakeholders
• Reviews, edits and approves change controls, SOPs, reports and other documentation
• Review and/or approve master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
• Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions.
• Trains/advises less experienced Specialists.
• May present at both internal and external (regulatory) audits if required.
• Stays current with industry trends, regulatory requirement updates, and presenting same to team
• Performs other duties assigned by Management.
• Some travel may be required.

Key Requirements

• BS/BA in Engineering, Chemistry, or Life Sciences with 7+ years of related experience within the Pharmaceutical or Medial Device industry
• Previous team/people management experience essential.
• Previous cleaning validation and steam in place experience is not essential
• Understanding of Biopharmaceutical Drug Substance manufacturing process an advantage.

For further information on this role in please contact Mark Wilson on 0860449473 or email talent@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given.  You have supplied us with your personal data in the process of applying for a position.  Our client company may have personnel outside of the EEA who will review you data.  We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Mark Wilson

JOB-13251

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