Manager, Laboratory Equipment Qualification
hace 1 semana
Proclinical are recruiting a Manager, Laboratory Equipment Qualification & Validation for a biotech establishment. This role is on a permanent basis and is located in Madrid. The client is focused on to produce a new generation of life-changing remedies for people.
**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 see-through project timelines independently.
- Know-how of pertinent and ongoing FDA, EU, ICH regulations and guidelines.
- Communication skills both verbally and in writing.
- Works well with others in a dynamic, cross-functional matrix setting.
- Capable of prioritising workload and accomplishing various projects and tasks simultaneously within a fast-paced work setting.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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TechOps
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