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Validation Specialist
Eingestellt von Quanta Consultancy Services
Gesuchte Skills: Support
Projektbeschreibung
Validation Specialist, on a 12 month contract, to work as part of a team in establishment of a Global Biologics Testing Laboratory.
Role and Responsibilities:
* 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.
Requirements:
* 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 a minimum 3 years experience in a pharmaceutical environment, at least 1 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
Role and Responsibilities:
* 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.
Requirements:
* 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 a minimum 3 years experience in a pharmaceutical environment, at least 1 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