For more information, please copy and paste this link into your browser: https://secure-jobsplus.gov.mt/Filerepository/Jobsplus/APL_QAO.pdf
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. 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.
If multiple Education and Language Profiles are defined, please note that you must fit at least one of them, but not necessarily all.
| Subject | Level | Grade |
|---|---|---|
| APPLIED SCIENCE | FIRST DEGREE / BACHELORATE | N.A. |
