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Quality Assurance Specialist | Hybrid

  • Sector: Science & Pharma
  • Contact Email: emma.cawley@collinsmcnicholas.ie
  • Job Ref: 20383

Are you looking for an exciting new opportunity to advance your career in Life Sciences? We are currently looking for a Quality Assurance Specialist to join a Biopharmaceutical Company located in Sligo. This role is initially a 12-month contract but has the potential to lead to a permanent position. Not only does this role offer a competitive salary and benefits package (outlined below), but it will also provide the successful candidate with exposure to state-of-the-art scientific technologies and techniques that will assist their career advancement.

What You'll Receive

  • Hybrid Working Options
  • Pension
  • Healthcare
  • Flexi-time
  • 22 Days Holidays
  • Life Assurance
  • Income Protection

Responsibilities | Detailed Job Description Available on Request

As a member of the Quality team, your duties will include:

  • Site QA point of contact providing technical expertise, feedback, and guidance for QA and compliance topics /issues including validation strategy /approach, new product introduction, and manufacturing and assisting in the resolution of issues commensurate with the level of risk
  • Manage assigned areas of the Quality Management System (QMS) to ensure the manufacture of products in accordance with GMP and regulatory requirements
  • QMS areas of responsibility include Deviation, Change Control, and CAPA management systems; Internal/External audits; Customer Complaints; Vendor Management; review /approval of Manufacturing Batch Records and assessment /approval of production materials
  • Generate, review, and approve SOPs/other documentation as applicable to your areas of responsibility
  • Review and approval of validation protocols/ reports and related documentation to ensure compliance with current EU regulatory expectations and site procedures
  • Ensure schedules for review and approval of GMP /validation documents are maintained to support technology transfers and new product introduction project timelines
  • Act as the QA lead in QA activities in project work-streams involving cross-functional, multidepartment teams including Operations, Quality Control, Quality Assurance, Engineering, and others

Requirements

As a Quality Assurance Specialist, you will be required to have:

  • A minimum of 3 years minimum experience working in a GMP Quality environment
  • Experience in a Validation function with strong knowledge of Project Life Cycle and cGMP Regulations

If this Quality Assurance role interests you, please contact Emma Cawley today.

emma.cawley@collinsmcnicholas.ie