CK QLS are recruiting for a C&Q Engineer to join an important project with a global Pharmaceutical Company at their site based in Bern on a contract basis until the end of the year.
C&Q Engineer Role: The main purpose of the role will be to:
- Ensure that 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.
- Ensure that Qualification/Validation Master plansare 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 collaborationwith internal and external partners.
- Coordination and oversight of external suppliers.
- Operational handling of Change Controls, CAPAs and Non-Conformances related to qualification topics.
- You will be especially dedicated to activities related to thermal mapping and autoclave.
Your Background: In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- 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 (c)GMP regulations.
- 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.
Apply: For more information or to applyfor this C&Q Engineer position, please contact Adrien on 0041 (0) 800 106 106 or email firstname.lastname@example.org, quoting job ref 51216.
Please could you send any correspondence in English.
It is essential that applicants hold entitlement to work in Switzerland.