C&Q Engineer
- Employer
- Proclinical Staffing
- Location
- Switzerland
- Salary
- Negotiable
- Start date
- 24 May 2022
- Closing date
- 7 Jun 2022
View more
- Discipline
- Manufacturing, Engineering
- Hours
- Full Time
- Contract Type
- Contract
- Experience Level
- Experienced (non-manager)
Job Details
Proclinical are recruiting a C&Q Engineer for a pharmaceutical establishment. This role is on a contract basis and is located in Bern. The client is focused on aiding the world in being a healthier community.
Responsibilities:
- Plan, assess and sanction technical and GMP linked documents such as URS, FMEA, impact/risk assessment, Master plans, qualification/validation documentation.
- By cooperating with associates on an internal and external basis, you will organise and implement FAT/SAT, commissioning actions for new GMP systems.
- Ensure the Qualification/Validation Master plans are kept up to date and inaugurated for all current projects.
- You will transcribe/evaluate qualification/validation plans which involve, DQ, IQ, OQ, PQ plans/procedures and final documents for new or altered GMP utilities, facilities, and process equipment.
- Guarantee that the Qualification/Validation stages are conducted rendering to international and regional organisation policies and procedures, as well as any legal necessities and needs set by regulatory authorities.
- Prepare and follow implementation of commissioning & qualification actions/documents vs. project(s) deadlines.
- The ideal candidate will organise and supervise external providers.
- Implement DQ, IQ, OQ, PQ, which involves procedure aberrations, examination, and corrective measure actions for new or altered GMP utilities, amenities and process equipment.
Skills & Requirements:
- Educated to a degree level in a natural or technical science discipline.
- At least 3 years of experience in a pharma industry serving as a C&Q/CQV role.
- Knowledge on qualification necessities rendering to cGMP guidelines.
- Past involvement with cooperating with cross-division shareholders.
- Quality assurance principles knowledge.
- Familiarity operating in a project team on various projects separately.
- Acquaintance working with ISPE baseline guide vol 3, vol 4 and vol 5 would be beneficial.
- Communication skills with the ability to think analytically and resolve issues.
- Fluency in the English language with knowledge in German.
- Capable of managing time efficiently.
If you are having difficulty in applying or if you have any questions, please contact Sasha Botha at +41 61 568 79 88.
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.
#LI-SB6
#QACompliance
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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