About the job

Immediate Vacancy: QA Officer

Working within the Quality Department, this position requires the selected candidate to ensure effective interaction and communication across several departments such as ABT Innovia (the contract research arm of the organisation), ABT Laboratories, and other departments as and when required. The role will also include the review and approval of validation documentation (in accordance with Good Manufacturing Practice) and activities related to the qualification of the facility, equipment, and utilities to support start-up and on-going testing and batch release.

Synopsis of position offered

This position is only open for EU/EEA/UK passport holders or TCNs presently residing in the EU with the required permits.

A position within the AquaBioTech Group has arisen for a suitably qualified/experienced person to work as a QA Officer within the Quality Department. The responsibilities of the selected candidate are defined as follows:

• Ensuring quality processes are established and conducted in accordance with the relevant guidelines, regulations and processes.
• Reviewing records and change requests on completeness, consistency, relevance and clarity.
• Where appropriate, providing advice to requesting departments regarding Good Manufacturing Practice (GMP)/Good Laboratory Practice (GLP) matters and compliance.
• Reviewing and preparing batch release documentation.
• Quality Management System (QMS) responsibility for deviations management and reviewing and approval of QA-controlled documentation (such as SOPs, batch records, working instructions).
• Support for the development of appropriate Corrective and Preventative Actions (CAPAs) and continuous improvement activities.
• Scheduling and conducting various audit types (GMP, Study, Facility, Process) as specified in the Quality Assurance Plan (QAP) to determine compliance with the principles of GMP/GLP. This includes organisation, follow-up, and participation of official authority audits.
• Organisation and conduct of GMP/GLP related training (e.g. Good Documentation Practices).
• Performance of qualification/technical visits at vendor sites to support the appropriate vendor selection and supplier qualification.
• Perform timely review and approval of site procedures and documentation to ensure compliance with GMP/GLP and regulatory requirements.
• Actively contribute to continuous improvement activities.
• Approval of official documentation in the absence of the Head of Quality. (Studies, Qualifications, etc.)
• Other duties as assigned.

Reporting directly to the Head of Quality and Regulatory Compliance, the position requires a person who is highly organised, has an eye for detail, and is an independent thinker. The selected person should be prepared to debate positions in a robust but professional and respectful manner. Additionally, the post holder will be expected to develop good working relationships with key staff across the delivery units, such as the CRO Director, Head of Ecotoxicology, laboratory supervisor and CRO facility manager.

Qualifications and Experience Overview

The successful candidate must have a minimum of a tertiary level education qualification in Chemistry/Biology, and/or a minimum of a secondary level of education and two (2) years’ experience working in Quality Management.

The selected candidate will be required to speak and write English fluently, and knowledge of any other languages would be considered an asset, although not essential.

The selected candidate must have a clean EU / EEA passport OR be a third-country national (TCN) presently residing in the EU with no travel restrictions or legal convictions and be in possession of a clean driving licence.

Financial Package

The successful candidate will be offered a long-term, fixed-term contract with the company. The starting package offered for this position will be structured upon the chosen candidate, reflecting the experience the candidate brings to the company, but also in line with the cost of living in Malta and could include an accommodation package, if required.

Application Procedure

Further information about the AquaBioTech Group and the services we offer can be viewed at www.aquabt.com. Applicants are required to submit a full Curriculum vitae to recruitment@aquabt.com. Questions about the application should be directed to the Director of Administration, on hr@aquabt.com.

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