Arbetsbeskrivning

Job description Assists the Quality Assurance Manager in the day-to-day operation and management of the quality system according to EU GMP and GDP. ? 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. Requirements ? English language skills ? Diploma/Degree in Sciences Training provided Induction Training On the job training Any assistance with accommodation/relocation One time re allocation bonus to anyone reallocating from outside of Malta Any other benefits ? Health Insurance ? Gym Benefits ? Mobile and home plan internet benefits Salary 24,000 - 26,000 EUR per year How will the interviews be held Online To apply CVs and a covering email are to be sent by email to [email protected] and should be written in English. Please quote the vacancy name and number in your email.