QA Specialist - Senior

Work Arrangement: Hybrid (flexibility required)
Experience Required: Minimum 3 years in a sterile or aseptic pharmaceutical environment (more preferred)

Key Duties and Responsibilities

• Perform Batch Record Review and material release, including Certificates of Analysis (CoA), ensuring full GMP compliance.

• Review and approve Master Batch Records (MBR) for routine cleaning and manufacturing activities, including automation recipe updates.

• Review and approve SOPs, Work Instructions, and Forms from cross-functional departments.

• Attend and actively contribute to Daily and Weekly Operations-led Team Meetings.

• Lead and participate in Gemba Walkdowns and Inspection Readiness Walkdowns from a QA perspective.

• Review and approve Warehouse Shipping Picklists.

• Act as the primary QA point of contact for Quarantine Shipments and the Returns process.

• Manage Batch Book filing and archival in line with regulatory and company requirements.

• Review, approve, initiate, and own Quality Non-Conformance (NC) records, including customer complaint NCs.

• Conduct periodic reviews of QA and Quality Systems SOPs.

• Serve as the primary Quality representative at Root Cause Analysis (RCA) meetings.

Key Skills and Competencies

• Builds strong, productive relationships across teams and stakeholders.

• Demonstrates the ability to work effectively independently and within teams.

• Proactively seeks opportunities for professional growth and development.

• Applies best practices to improve business and quality operations.

• Holds self accountable for compliant, right-first-time execution.

• Takes ownership of decisions that add customer and business value.

• Adapts effectively to change in a dynamic environment.

• Consistently demonstrates integrity and Credo-based behaviors.

• Strong time management skills with the ability to meet deadlines.

Education and Experience Requirements

• • Third-level degree in a Science or Pharmaceutical discipline.

  • Minimum 3 years’ experience in the pharmaceutical industry, must be within a sterile or aseptic manufacturing environment.
    

  • Working knowledge of Quality Systems and QA processes is desirable.

  • Demonstrated knowledge and application of global regulatory requirements, including FDA, HPRA, EMA (EMEA) and other relevant authorities.

Our Vision: To be recognised as the best STEM Contracting & Permanent Recruitment company and the Employer of Choice for top performing Recruiters.

For further information on this role please contact Geraldine Gormally on 0861071395  / recruit@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 your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel