C&Q Consultant

Job Description

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas. Due to our constant growth, we are looking for a C&Q Consultant based in Melbourne, Australia. You will be responsible for: Commissioning and trouble shooting during Startup+Debug phase of the filling line Management of qualification and test plans according to specific technical requirements, requirements-testing traceability matrixes and design qualification and summary reports Drafting, verification and execution of protocols and qualification test (FAT, SAT, IQ, OQ, PQ) Installation, operational and performance qualification protocols for equipment and utilities (e.g.: HVAC, Water Systems, Process Gases), according to the current internationally recognized guidelines (e.g.: ISPE, GAMP) Drafting of thermal validation study protocols Development of project validation master plans for new sites implementation including detailed Gantt charts with resources workload evaluation (advanced knowledge of Microsoft Project requested) Risk-based process analysis according to international methodologies (e.g.: FMEA, HACCP) Creation of calibration and maintenance plans and related instructions Standardization of operating procedures Calibration of devices (automatic and manual) About you: Technical Degree (Engineering, Chemistry, Biotechnology, Informatics, Physics, Mathematics) Minimum of 3-4 years of experience in Pharmaceutical Sector Knowledge of FAT, SAT, IQ, OQ, PQ procedures and documentation Knowledge of the main test instruments suites (e.g.: Client Kaye Validator, Thermal validation studies data loggers, HVAC test instruments, calibration instruments) Integrity, strong ethics, analytical skills and attention to details Full availability to travel in EU Next Steps: Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview. If there's a positive match, a technical interview with the Hiring Manager will be arranged. In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal. Alternatively, if the outcome is negative, we will contact you to halt the recruitment process. Working at PQE Group As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world. If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you. Apply now and take the first step towards an amazing future with us. Seniority level Mid-Senior level Employment type Full-time Job function Project Management, Production, and Quality Assurance Industries Business Consulting and Services #J-18808-Ljbffr