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Quality Specialist

Job description

Role Title: Quality Specialist
Location: North Dublin
Role Type: Contract

Force Recruitment have partnered with a leading biopharmaceutical manufacturer based in North Dublin to hire a Quality Specialist on a contract basis. The Quality Specialist ensures quality and compliance of products manufactured  and adherence to Good Manufacturing and Documentation Practices.
The role requires 5 years’ experience in a GMP Manufacturing or Laboratory environment, preferably in Pharmaceutical/Biological Quality Operations.

  • Participates as the quality member on cross functional projects

  • Responsible for review/approval of new and updated Master Batch Records / Electronic Batch Records

  • Reviews executed production documentation such as electronic batch records and logbooks to ensure accuracy and compliance with cGMPs and company procedures and ensures completion of proper remediation of errors

  • Provides presence on the shop floor to support compliance and data integrity

  • Review & approve new and updated SOPs/ Work Instructions and Controlled Job Aides

  • Actively participates in the Tier process and use this forum to make concerns visible and to partner with the functional area on resolution

  • QA support, review and approval of Commissioning and Qualification lifecycle documents for capital projects and new equipment.

  • Will serve as the Quality SME for Performance qualification (PQ) activities across the site including but not limited to: Equipment, Facility and Utility PQ studies, Cleaning Validation, SIP, process validation,

  • Support sustaining activities such as Change Management, Deviations, CAPAs, Equipment Requalification and Periodic review, Site Maintenance & Calibration Program

  • Provides support to internal audits and regulatory inspections

  • Collaborates with cross-functional team members in the identification and implementation of continuous improvement initiatives and action plans

Qualifications & Experience:

  • BSc in Science or related

  • 5 years’ experience in a GMP Manufacturing or Laboratory environment

  • Excellent leaderships and communication skills

  • cGMPs and of regulatory requirements as they apply to the pharmaceutical field

  • Experience with quality systems, pharmaceutical manufacturing or laboratory processes, authoring and approving GMP documents