C&Q Engineer (JJJP00007924)
QLS are recruiting for a C&Q Engineer to join an important project with a Global Biopharmaceutical Company at their site based in Bern on a contract basis until 30th of April 2022.
Main responsibilities:
- 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
- Qualification/Validation Master plans are up to date and established for all ongoing projects• Write/review Qualification/Validation plans, including but not limited to DQ, IQ, OQ, PQ plans/protocols and final reports for new or modified GMP utilities, facilities, and process equipment
- Execution of DQ, IQ, OQ, PQ, including protocol deviations, investigation, and corrective action activities for new or modified GMP utilities, facilities, and process equipment
- Plan and track execution of Commissioning & Qualification activities/documentation versus project(s) timeline
- Prepare,review and approve technical and GMP related documentation (URS, FMEA, impact/risk assessment, Master plans, qualification/validation documentation)
- Coordinate and execute FAT/SAT, commissioning activities for new GMP systems in collaboration with internal and external partners
- Coordination and oversight of external suppliers
Candidate’s Requirements:
- Bachelor/Master’s degree in technical or natural sciences
- A minimum of 5 years of working experience within pharma company inC&Q/CQV equivalent position
- Know-how of Qualification requirements according to cGMP regulations
- Experience working with cross-department stakeholders
- Know-how of quality assurance principles
- Experience working in project teams and multiple projects in parallel
- Experience working with ISPE baseline guide vol 3, vol 4 and vol 5 is a plus
- Excellent communication skills
- Analytical thinking and problem-solving ability
- Business fluency in English
- German language is a plus
- Self time management
For more information or to apply for this position, please contact Adrien on 0041 (0) 800 106 106 or email aguimard@ckqls.ch. Please could you send any correspondence in English. Please quote reference QLS 00051926 in all correspondence.
INDQLS