Quality Assurance Officer

EURES Malta

• Distribution and control of quality documentation.
• Update 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.
• Ensure all new and existing equipment is assessed appropriately and validated for its intended use.
Coordinates procedure/ process testing and provides reviews of audit trails.
• Ensure 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.
• Perform 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.
• Assist the Quality Assurance Manager during regulatory and customer audits.
• Carry out other duties as may reasonably be required.

bakalaureus

• Bachelor’s degree in Pharmacy, Chemistry, Biology, or related scientific field.
• Minimum 1–3 years’ experience in a pharmaceutical QA environment (preferred).
• Strong understanding of GMP, GDP, and regulatory guidelines (FDA, EMA, WHO).
• Excellent attention to detail and documentation skills.
• Strong analytical, problem-solving, and communication abilities.
• Ability to work independently and as part of a team.

Training provided
On the job training, induction training
Any assistance with accommodation/relocation
€ 500 Reallocation Allowance paid one time with 1st Salary.
Any other benefits
Health Insurance
Gym Membership deductions