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Duties
A position within the AquaBioTech Group has arisen for a suitably qualified/experienced person to
work as a QA & Compliance Deputy 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.)
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.
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.
work as a QA & Compliance Deputy 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.)
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.
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.
Requirements for candidate
Language skills
| Language | Oral | Written |
|---|---|---|
| EN required | C1 | C1 |
Other requirements
• 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.
We offer
Training provided
Successful candidates will go through our internal onboarding procedure, whereas all information and
documentation will be provided before start date, for information and signing. Technical training will
also be provided, specific to the role and skills assessment of the selected individual.
Any assistance with accommodation/relocation
AquaBioTech Group offers all employees company accommodation, which comes at cheaper rates
compared to personal renting, and which will be available immediately for new employees to use upon
their arrival. All preparation related to accommodation is handled by the company.
Any other benefits
For those positions within the company that require compliance with a changing and dynamic roster,
and who are susceptible to working public holidays, will be given those days back to be used as leave
allocation.
Salary
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.
How will the interviews be held
Both online and in-person interviews will be held, depending on the location of the individual.
Successful candidates will go through our internal onboarding procedure, whereas all information and
documentation will be provided before start date, for information and signing. Technical training will
also be provided, specific to the role and skills assessment of the selected individual.
Any assistance with accommodation/relocation
AquaBioTech Group offers all employees company accommodation, which comes at cheaper rates
compared to personal renting, and which will be available immediately for new employees to use upon
their arrival. All preparation related to accommodation is handled by the company.
Any other benefits
For those positions within the company that require compliance with a changing and dynamic roster,
and who are susceptible to working public holidays, will be given those days back to be used as leave
allocation.
Salary
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.
How will the interviews be held
Both online and in-person interviews will be held, depending on the location of the individual.
Information about job
Office location
Malta
Number of openings
1
Remuneration (gross)
(24 000 - 29 000 EUR/yearly)
Working time
Fulltime
Duration of employment
tähtajaline
Application information
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 (QA & Compliance Deputy (Ref: 410269)).
be written in English.
Please quote the vacancy name and number in your email (QA & Compliance Deputy (Ref: 410269)).
Deadline for the submission of applications
2024-11-11
Required documents
CV
kaaskiri
Contact person
David Muscat , EURES Malta, +356 2220 1663, [email protected]
See additional information and apply here
Latvia
Lithuania
Slovenia
