Commissioning, Qualification and Validation (CQV) Consultant

PQE Group; Melbourne; Vor Ort; AUD 110.000 - 160.000; Vollzeit

Zusammenfassung

PQE Group in Melbourne is seeking a Commissioning, Qualification and Validation (CQV) Consultant to lead HVAC and cleanroom projects in the pharmaceutical and medical device sectors. You will drive URS, DQ, IQ/OQ/PQ activities and ensure GMP compliance across the lifecycle documentation.

Join a global team delivering international projects, with opportunities to collaborate across diverse sites while travelling domestically and abroad as required.

Qualifikationen

• Bachelor's degree in a relevant field (Pharmacy, Pharma Chemistry, Microbiology, Chemistry or Engineering).
• At least 1 year of relevant work experience.
• GxP industry experience with process and engineering systems/services.
• Good knowledge of cGMP guidelines and data integrity principles.

Aufgaben

• Lead and deliver project objectives, controlling scope to meet budget and schedule.
• Ensure compliance with GMP and QA lifecycle documentation.
• Ensure safe, healthy and secure workplaces for staff and contractors.
• Manage GMP risk and non-compliance risks actively.
• Assist in planning plant shutdowns and co-ordinate activities.
• Develop operational and maintenance manuals and training materials.
• Complete tasks on scope, on budget and on time with zero harm and cash-flow targets.
• Broad experience in HVAC and Cleanrooms Commissioning/Qualification (URS, DQ, FAT, SAT, IQ, OQ, PQ).
• Draft/review Quality Risk Assessments, QMS SOPs, CAPAs and Change Control.

Kenntnisse

GxP knowledge

Data integrity principles

Project management

Travel willingness

Ausbildung

Bachelor's degree in Pharmacy/Pharma Chemistry/Engineering

Jobbeschreibung

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 a constant growth, PQE is looking for a Commissioning, qualification nd Validation (CQV) Consultant based in Melbourne, Australia.

Your responabilities:

• Lead and deliver the project objectives, controlling scope changes to meet budget and schedule, functionality according to the URSs, Equipment TRSs, GMP, safety and environmental requirements during all phases of the project (Design, Procurement, and Quality Assurance)
• Ensure compliance with Current Good Manufacturing Practice as applicable to this role and customer global and local quality policies.
• Ensure the Quality Assurance of the lifecycle documentation produced.
• Ensure that project tasks are managed in a way that creates a safe, healthy and secure workplace for the staff and contractors involved in implementing projects and for those using the facilities created or modified by these projects.
• Ensure that project tasks are managed in a way that recognizes GMP and the need to actively manage the risk of non-compliance.
• Assist in planning and co-ordination of any plant shutdown activities.
• Assist in or manage as directed, the development of operational and maintenance manuals and training materials.
• Complete project tasks from start to finish, so that they are completed to scope, within budget and on time while achieving zero harm, identified returns and meeting cash flow requirements.
• Broad experience in HVAC and Cleanrooms Commissioning and Qualification activities i.e. URS, Design aspects, DQ, FAT, SAT, IQ, OQ and PQ documentation.
• Preparation of Quality Risk Assessment, Drafting/reviewing of QMS SOPs, Quality Risk Management, Complaints, deviations and CAPAs management, Change Control management

Skills Required:

• At least a Bachelors Degree (Pharmacy, Pharmaceutical Chemistry, Microbiology, Chemistry, Engineering)
• At least 1 years of relevant work experience;
• An underlying process and engineering systems/services experience gained in the GxP industry
• Good knowledge of cGMP guidelines and Data integrity principles
• Full availability to travel domestically and abroad

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.