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QA Specialist - Systems & Compliance - Pharmaceutical

  1. Dublin
  1. Contract
Competitive
26592WP
  1. Compliance / Quality Assurance
Date Posted06 Apr 2021
QA Specialist - QA Systems & Compliance -  8 months +

Biopharmaceutical manufacturing plant have a contract requirement for a QA specialist to join the Quality systems & compliance team.  

You will will provide QA oversight and support qualification, technical transfers, regulatory approvals and commercial operations. The role will support the biologics Drug Substance manufacturing operations and will be responsible for release testing and batch certification for finished drug product.


Responsibilities will include (but not limited to):
  • Support Material disposition of raw materials and consumables for the site
  • Support the Supplier Quality Management program.
  • Support the Material Qualification program.
  • Support the administration of Product Quality Complaints (PQC) including processing, and maintenance of site PQC program.
  • Support the QA Documentation systems on site.
  • Support the administration of Change Control system.
  • Support and maintain the Quality Risk Management program.
  • Support of Regulatory and Corporate Inspections and achievement of market approvals.
  • Co-ordination and support of the CAPA system, Global Regulatory Observation Evaluations.
  • Participates in the Site Self-Inspection Program by conducting audits of site functions.
  • Interface with the relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements.
  • Authoring, review and approval of QA-related procedures.
  • Support Quality Council and Quality Site Metrics generation.
  • Support OPEX programs and champion continuous quality improvement initiatives.
 
Qualifications and Experience required:
  • The successful candidate will hold a BSc in Science or related discipline
  • 3 years’ QA experience in a bio-pharmaceutical environment.
  • A clear understanding of cGMP requirements for quality systems and compliance is required
  • The candidate must be able to work across a team matrix in order to meet accelerated timelines. Excellent communication & presentation skills are essential

Call me for further information on this role!
 




The candidate must have the rights to work in the location stated in the job advert.

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