Farmaceut pre zabezpečenie kvality

Job description
• Ensures the day-to-day operation and management of the quality system according to EU GMP and GDP.
• Distribution and control of quality documentation.
• Updates QA documentation, maintain quality logs and document registers.
• Participates in the self-inspection program to audit operational practices and staff for compliance with
established documentation, policies and procedures.
• Perform training sessions on GMP/ Quality topics for company personnel.
• Compilation/ review of periodical Product Quality Reviews.
• Report all findings related to quality deviations in a report and if required, in a way that all relevant
parameters are traceable and easily understood.
• Assist in quality deviations and support the execution of corrective and preventative actions and related
documents to ensure compliance is achieved and maintained.
• Liaise and support department managers in the implementation of CAPA identified from the findings
related to deviation investigation.
• Assist the immediate superior in problem solving exercises and other exercises aimed at improving quality
and efficiency.
• Receipt, reporting of customer complaints and follow-up investigations with the manufacturer and the
customer.
• Analytical test methods and specifications regulatory compliance review.
• Review and distribution of the Product Approval Package (PAP).
• Review and approval of Printed Packaging Materials Artwork.
• Review and maintenance of (Item) Master Data in Oracle.
• Maintenance of Supplier audits and qualification system.
• Verification and maintenance of suppliers/ customers certifications and licensing status.
• Review and maintenance of Business Partners Master Data in Oracle.
• Upkeep and maintenance of Quality Technical Agreements and Service Agreements.
• Oversees the manufacturers’ change control program in relation to regulatory updates.
• Review CAPAs to ensure all actions are implemented and adhered to for quality compliance. Oversees
the CAPA Program to monitor the effectiveness of CAPA, as a means of continuous improvement.
• Reviews and process internal change requests. Participates in Change Control assessments, as
required, and project meetings to ensure the compliant status of affected equipment/ systems/ processes
is not compromised.
Vacancy additional information
• To liaise effectively with other departments to ensure assigned validation exercises are conducted in a
timely manner and in compliance with GMP.
• Ensures all new and existing equipment is assessed appropriately and validated for its intended use.
Coordinates procedure/ process testing and provides reviews of audit trails.
• Ensures all software used for the generation of Good Manufacturing Practices (GMP) activities meets the
standards required for data integrity compliance.
• Review of protocols and reports from other departments/ companies.
• Performs risk assessments to determine high risk equipment and determines appropriate corrective
action.
• Upkeep and maintenance of local product Marketing Authorisations (pertaining to MAH: Aurobindo
Pharma Malta).
• Participate in quality audits of Aurobindo and third-party API and finished dosage form manufacturing
sites.
• Assists the Quality Assurance Manager during regulatory and customer audits.
• Carry out other duties as may reasonably be required.

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EURES poradca: Mgr. Ferdinand Bolibruch
Email: ferdinand.bolibruch@upsvr.gov.sk
Telefón: 043/2445303