Quality Assurance Manager

1 week ago

Melbourne, Australia PQE Australia Pty Ltd Full time

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 continuous expansion, we are currently looking for a **Quality Assurance Manager** to join our team in Melbourne, Australia.

**Responsibilities**
- 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

**Requirements**:

- At least a Bachelors Degree (Pharmacy, Pharmaceutical Chemistry, Microbiology, Chemistry, Engineering)
- At least **2 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
- English and Spanish Fluent (mandatory)
- Full availability to travel domestically and abroad

**Working at PQE Group

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