Quality Assurance Manager

3 settimane fa


Nicosia, Sicilia, Italia GRS Recruitment A tempo pieno
Quality Assurance Manager

GRS Recruitment is seeking a highly experienced Quality Assurance Manager to join a leading pharmaceutical company in Nicosia. The successful candidate will have extensive working experience in a similar role within the pharmaceutical industry and a deep understanding of quality systems as defined under the EU-cGMP.

Main Responsibilities:
  • Ensure the company's Quality system is in line with current cGMP requirements and with any other relevant legislation.
  • Implement and maintain the company's documentation system in accordance with current cGMP.
  • Ensure that production, warehousing, quality assurance, and quality control activities are in line with current cGMP.
  • Keep the company's quality system up to date by implementing new guidelines or other legal requirements.
  • Draft and maintain high-level documents such as the Site Master File, Validation Master Plan, and SOP list.
  • Participate in management reviews of process performance, product quality, and quality management system, advocating continual improvement.
  • Establish a timely and effective communication and escalation process for quality issues.
  • Define responsibilities for Pharmacovigilance activities and perform internal audits on a periodic basis.
  • Conduct Product Quality Reviews.
  • Control and evaluate QA key indicators such as complaints, recalls, maintenance, calibration, and performance checks.
  • Supervise GMP/QC-GLP assessments of QC/Production/Warehouse areas.
  • Perform training of personnel on GMP/QC-GLP concepts and review for re-training needs.
  • Participate in annual self-inspections and prepare relevant documentation.
  • Qualify/audit/review local material suppliers/contract laboratories and prepare audit reports.
  • Participate in audits by authorities and customers.
  • Prepare/co-ordinate/monitor/complete corrective action plans and related documentation.
  • Monitor supplier qualification and ensure all GMP-related vendors are qualified according to written procedures.

Candidate Profile:
  • At least 10 years of working experience in a similar role within the pharmaceutical industry.
  • Extensive knowledge of relevant quality guidelines (ICH, WHO, etc.).
  • Excellent knowledge and understanding of Quality System as defined under the EU-cGMP.
  • Fluency in English language, both written and verbal.
  • Registered Qualified Person in Cyprus or another EU Member State is an advantage.

Company Benefits:
  • 13th salary.
  • Provident fund.
  • Flexible Working Hours.

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