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Quality Assurance Specialist

Reference:SGAJOW-106063 Location: Carlow
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: €45000 - €50000
May be suitable for: Quality Specialist, EHS Specialist

Quality Assurance Specialist

Life Science Recruitment, on behalf of our client are sourcing a Quality Assurance Specialist for a biologics focused position. The Quality Specialist will participate as a core member of the Integrated Process Team and as a member of the Quality Centre of Excellence (CoE).

Roles & Responsibilities

  • Attend and actively contribute to daily Tier meetings.
  • Complete pre and post production batch record review.
  • Support development, clinical and commercial production.
  • Release incoming materials.
  • Provide Quality support OOS/deviations, providing detailed knowledge of quality systems in place and ensure that root cause is identified and corrective actions as appropriate are completed (CAPA).
  • Review and approve master cleaning documentation, including; technical assessments, cleaning protocols, inspection protocols and Master Cleaning Batch records.
  • Generation of Technical & Quality agreements.
  • Annual Process and Systems Reviews: Prepare and coordinate the review and approval of the Annual Product Review Schedule.
  • Prepare annual process and systems reviews, including the annual mock recall, as determined by the Annual Product Review (APR) Schedule.
  • Investigate Supplier Complaints / Raw Material Deviations / Customer Complaints.
  • QA Review of Regulatory Data: Review and verify documentation that may be used for regulatory submissions/filings.
  • Assure the accuracy and integrity of all data and information through a timely review program.
  • Lead walk down audits.
  • Participate in the preparation for and hosting of regulatory and customer audits.
  • Participate in Quality and site projects that may arise.
  • The position will provide an opportunity to develop strong Quality and Technical understanding of Operations and Compliance requirements in the Pharmaceutical Industry.

Skills & Qualifications

  • Bachelor's degree or post-graduate qualification in Science, Pharmacy or Engineering field.
  • Previous experience in Quality Assurance / Compliance within a biologics function is essential.
  • Excellent understanding of the current pharmaceutical industry regulations (FDA/EU/ICH).
  • Practical experience in the implementation of quality systems in a pharmaceutical manufacturing environment.
  • Preferred Competencies and Skills:
  • Operate as part of a self-directed team in carrying out day to day functions and assigning priorities.
  • Knowledge of global health authority regulations and quality and compliance requirements with the ability to effectively communicate these requirements.
  • Hands-on experience in investigating root cause analysis
  • Demonstrated ability to make and act on decisions.
  • Ability to provide innovative ideas to improve quality and compliance that create value.
  • Experience supporting regulatory inspections.
  • Analytical problem-solving skills applied to issue identification and resolution.
  • Ability to respond to changing priorities.

If you would like further Information you can contact the recruiter directly:

Simon Gillivan | Tel: +353 (0) 1 507 9258