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Lab Validation Specialist
Eingestellt von Quanta Consultancy Services
Gesuchte Skills: Support
Projektbeschreibung
A global pharmaceutical organisation, based in Ireland, is seeking to recruit a Validation Specialist on a 12 month contract to work as part of a team in establishment of a Global Biologics Testing Laboratory.
Reporting to the Laboratory Compliance QA Manager, the Validation Specialist will be responsible for:
* Change control assessment and review for all laboratory instrumentation and control system installations.
* Review and approval of all laboratory instrumentation, equipment, control systems qualification and documentation.
* Authoring, review and approval of appropriate Validation related procedures and philosophy documents. The role will may also require providing support for more general QA systems activities as required.
A clear understanding of cGMP requirements of laboratory equipment and instrumentation qualification, in addition to 21 CFR Part 11 compliance, is required. A knowledge of ICH guidelines, FDA regulations and a working knowledge of GAMP guidelines would prove advantageous.
The successful candidate will hold a BSc in Biochemistry (or science related discipline), or a BEng, with minimum three years experience in a pharmaceutical environment, at least one of which was in a Validation role. A strong working knowledge of US and EU GMP regulations and the principles of qualification and validation would be beneficial, but not essential. The successful candidate will be able to demonstrate excellent time management and organisational skills, along with a proven ability to multi-task.
The Validation Specialist will be required to work on his/her own initiative, as much as working as part of a team. As such, excellent interaction, communication and presentation skills are necessary to be successful in the role.
If this is you please apply today!
Reporting to the Laboratory Compliance QA Manager, the Validation Specialist will be responsible for:
* Change control assessment and review for all laboratory instrumentation and control system installations.
* Review and approval of all laboratory instrumentation, equipment, control systems qualification and documentation.
* Authoring, review and approval of appropriate Validation related procedures and philosophy documents. The role will may also require providing support for more general QA systems activities as required.
A clear understanding of cGMP requirements of laboratory equipment and instrumentation qualification, in addition to 21 CFR Part 11 compliance, is required. A knowledge of ICH guidelines, FDA regulations and a working knowledge of GAMP guidelines would prove advantageous.
The successful candidate will hold a BSc in Biochemistry (or science related discipline), or a BEng, with minimum three years experience in a pharmaceutical environment, at least one of which was in a Validation role. A strong working knowledge of US and EU GMP regulations and the principles of qualification and validation would be beneficial, but not essential. The successful candidate will be able to demonstrate excellent time management and organisational skills, along with a proven ability to multi-task.
The Validation Specialist will be required to work on his/her own initiative, as much as working as part of a team. As such, excellent interaction, communication and presentation skills are necessary to be successful in the role.
If this is you please apply today!
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Sonstiges