CareerFinders, on behalf of our client, a leading Pharmaceutical company with a broad portfolio of products, we are seeking to recruit a Quality Assurance Manager to join their growing team based in Nicosia. The successful applicant will primarily be responsible for ensuring that the overall Quality System of the company is in line with current cGMP requirements, as well as any other relevant legislation that may apply. Our client is seeking applicants who hold relevant experience within a Quality Assurance role, who possess proven knowledge and understanding of Quality Systems as defined under the EU-cGMP. Excellent verbal and written communication skills in English are essential. 

Key Duties/Responsibilities: 

• Ensure the Quality System is in line with current cGMP requirements, as well as any other relevant legislation.
• Ensure the documentation system is correctly implemented and in line with current cGMP.
• Ensure that production, warehousing, quality assurance and quality control activities are in line with current cGMP.
• Keep quality system up to date by implementing any new guidelines or other legal requirements emanating from EU Directives.
• In particular, to draft and keep up to date high level documents such as but not limited to the company’s Site Master File, Validation Master Plan and the SOP list.
• Participate in management reviews of process performance, product quality and of the quality management system and advocating continual improvement.
• Ensure that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.
• To ensure that responsibilities with respect to Pharmacovigilance activities are duly defined and to perform the internal audit to the Pharmacovigilance department on a periodical basis.
• Ensure Product Quality Reviews are conducted.
• Control and evaluate other QA key indicators such as complaints and recalls, maintenance, calibration and performance checks programs and to monitor deviations, to supervise change controls and to approve corrective actions, changes and master documents.
• Periodically supervise (GMP/QC-GLP assessment) the QC/Production/Warehouse areas for quality deficiencies, related to personnel and premises.
• Perform training of personnel to the GMP/QC-GLP concept (Quality SOPs) (including induction, initial and periodical training-evaluation by GMP exams) and review for re-training needs.
• Participate in the annual self-inspection (internal audit) and to prepare the relevant documentation including reports and follow-up of CAPAs.
• Qualify/audit/review local material suppliers/contract laboratories and to prepare audit reports and follow CAPAs.
• Participate in audits by authorities and customers.
• Prepare/co-ordinate/monitor/complete the close-outs of corrective action plans and related documentation, after performed audits by authorities/customers.
• Monitor the qualification of suppliers and to ensure that all vendors related to GMP are qualified, according to written procedures.

Key Skills/Experience: 

• Proven experience in a relevant position in Quality Assurance.
• Extensive knowledge of relevant quality guidelines such as ICH, WHO etc…
• Excellent knowledge and understanding of Quality Systems as defined under the EU-cGMP.
• Excellent oral and written communication abilities in English.
• Registered Qualified Person in Cyprus or in another EU Member State will be considered an advantage.

To apply for this vacancy, please send your CV, along with any covering letter to jobs@careerfinders.com.cy quoting the reference number CAR7252. Please note that due to the high volumes of applications received only shortlisted applicants will be responded to. By sending us your CV you are giving CareerFinders your consent to be contacted for this and any other suitable vacancies that we believe match your skills and experience. To view our privacy policy, please click www.careerfinders.com.cy/privacy-policy.