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Junior Commissioning & Qualification Consultant

 

We are a service provider companyleader in the Pharmaceutical and Medical Device sectors since 1998, with more than 1500 employees45+ nationalities and 30 subsidiaries all over the world (Europe, Asia and the Americas). Joining PQE Group means being a part of a multicultural and challenging company, with many local and international projects and colleagues from all over the world.

Due to a constant growth, PQE Group is looking for Junior Commissioning & Qualification Consultant who will join our team in one of our offices in Italy.

Working in a consulting reality as PQE Group will give you:

  • The chance to work on projects for the most important national and international pharmaceutical companies;

  • Professional and quality training in order to help you reach success expressing your full potential and talent;

  • The opportunity to quickly increase your professional experience thanks to the constant support of a multicultural team of expert consultants.

Joining PQE will give you the opportunity to acquire the following professional competencies:

  • Support the 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

  • Support the 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

Requirements:

  • Technical Degree (Engineering, Chemistry, Biotechnology, Informatics, Physics, Mathematics)

  • 0-1 years of experience in the Pharmaceutical Sector

  • Italian Native/C1 and fluent English (B2/C1)

  • Integrity, strong ethics, analytical skills and attention to details

  • Availability to travel within the country and abroad up to 80% of the time

Nice to have:

  • Basic knowledge of FAT, SAT, IQ, OQ, PQ procedures and documentation

  • Knowledge of the main test instruments suites (e.g.: GE Kaye Validator, Thermal validation studies data loggers, HVAC test instruments, calibration instruments)

Location: Milan, Florence, Ascoli Piceno, Mirandola, Fidenza and Rome.

 

Our collaborators are engaged, developed, challenged and well-rewarded for performance.We recognize the importance of leadership at all levels of our organization in order to succeed in a challenging business environment, and we are committed to providing practical processes and programs to identify, develop and inspire all our current and future leaders.

 

Degrees of interest: Technical Degree (Engineering, Chemistry, Biotechnology, Informatics, Physics, Mathematics)

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Important: if the job description is in english, than also the motivation letter and the cv saved into the platform must be in english.


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