- Ensure the company's Quality system is in line with current cGMP requirements and with any other relevant legislation.
- Make sure that the company's documentation system is correctly implemented and in line with current cGMP.
- Ensure that the company's 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 any new guidelines or other legal requirements emanating from the E.U. 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.
- Ensure that responsibilities with respect to the company's Pharmacovigilance activities are duly defined and to perform the internal audit to the Pharmacovigilance department on a periodical basis.
- Make sure 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. CANDIDATE PROFILE
- Previous working experience of at least 10 years in a similar role within the pharmaceutical industry
- Extensive knowledge of the 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 in another EU Member State will be considered as an advantage. COMPANY BENEFITS
- 13th salary
- Provident fund
- Flexible Working Hours Due to the high volume of applications, we receive at GRS Recruitment, only shortlisted candidates will be responded to.
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Quality Assurance Manager - Nicosia, Sicily, Italia - GRS Recruitment
