C&Q Engineer
- Employer
- Proclinical Staffing
- Location
- Switzerland
- Salary
- Negotiable
- Start date
- 4 Aug 2021
- Closing date
- 18 Aug 2021
View more
- Discipline
- Manufacturing, Engineering
- Hours
- Full Time
- Contract Type
- Contract
- Experience Level
- Experienced (non-manager)
Job Details
Are you a C&Q Engineer interested in working for one of the most interesting names in High-Tech Biopharmaceuticals?
Are you looking for something new?!
A Fantastic new role has just opened up at one of our leading Swiss based clients offering the successful candidate the opportunity to join a hard-working team working on exciting projects in the pharmaceutical sector.
Responsibilities:
- In charge of commissioning and qualification (C&Q) activities for Technical Services department in order to ensure that: 1) Qualification/Validation phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities; 2) Qualification/Validation Master plans are up to date and established for all ongoing projects in QC
- Plan, coordinate and execute all phases for qualification of GMP manufacturing systems including but not limited to, Qualification/Validation plans, FMEA, DQ, IQ, OQ, PQ.
- Prepare, review and approve technical and GMP related documentation (URS, impact/risk assessment, Master plans, qualification/validation documentation)
- Coordinate and execute FAT/SAT, commissioning activities for new manufacturing systems in collaboration with internal and external partners
- Coordination and oversight of external suppliers
- Operational handling of Change Controls, CAPAs and Non-Conformances related to qualification topics
- THIS CONSULTANT WILL BE ESPECIALLY DEDICATED TO ACTIVITIES RELATED TO THERMAL MAPPING AND AUTOCLAVES.
Requirements:
- Bachelor/Master Degree in technical or natural sciences
- A minimum of 3 years of working experience within pharma company in C&Q equivalent position
- Know-how of Commissioning and Qualification requirements according to cGMP regulations and international guidelines
- Know-how of quality assurance principles and experience working with cross-department stakeholders
- Excellent communication skills
- Analytical thinking and problem-solving ability
- Business fluency in English
- German language is a plus
- Self time management
Company
At ProClinical we have one aim: to support life science companies in the many challenges they face while combatting unmet medical need worldwide.
Ageing populations, rare diseases, epidemics and the millions of patients without access to medication are just a few of the pressing issues that life science companies contend with. The industry is under increasing pressure to develop new and innovative ways to save and improve patients’ lives.
ProClinical’s mission is to support their work by connecting life science companies with the highly skilled professionals they need to continue innovating.
Internal recruitment and HR teams often struggle to continuously source skilled, experienced professionals to fill highly-specialised and niche roles. ProClinical combines a deep understanding of the industry with extensive candidate networks to provide both a technical and cultural fit for our life science partners.
- Website
- https://www.proclinical.com/
- Telephone
- 0800 988 4437
- Location
-
Eldon House
Eldon Street
London
EC2M 7LS
United Kingdom
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