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Manager, Laboratory Equipment Qualification
hace 3 meses
Responsibilities:
- Handle and own quality systems records linked to lab equipment, for example: deviations, change controls, CAPAs from start to finish, etc.
- Assist with efforts for tactical troubleshooting, remediation, change, and optimisation efforts in cross functional teams.
- You will write, update and uphold equipment/Instrument inventory, master file and SOPs.
- Supervise and discuss instrument lifecycle such as asset induction, move/decommission, CQV actions, etc., timelines with the use of project management tools.
- Conduct data entry, analysis, trending and evaluation using electronic/paper systems.
- Other duties may be assigned to the role.
Skills & Requirements:
- Educated to a degree level in a pertinent science with at least 10 years of experience working within a cGMP lab organisation.
- Past involvement in chemical, microbiology, or analytical instrumentation/software, method acquisition and instrument troubleshooting.
- Capable of resolving issues.
- An organised individual with the ability to seethrough project timelines independently.
- Knowhow of pertinent and ongoing FDA, EU, ICH regulations and guidelines.
- Communication skills both verbally and in writing.
- Works well with others in a dynamic, crossfunctional matrix setting.
- Capable of prioritising workload and accomplishing various projects and tasks simultaneously within a fastpaced work setting.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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