Commissioning Qualification Validation Manager

2 weeks ago

Sydney, Australia Quanta Full time

Commissioning Qualification Validation Manager
- Life Science
- Contract - Australia

Are you looking for your next Commissioning Qualification Validation Manager? We have an incredibly exciting new requirement that might just be for you.

Our client, a biopharmaceutical company based in Sydney, are looking for a Commissioning Qualification Validation Manager for their current project. They are on a mission to ensure lifesaving therapeutic plasma drugs are accessible to all - and as their newest Commissioning Qualification Validation Manager you can help them get there.

Commissioning Qualification Validation Manager Responsibilities:
Overall accountability for Validation including commissioning & qualification, computerized system validation, thermal validation, decontamination & sterilization validation, process validation, cleaning validation, transport qualification, aseptic process simulation and validation maintenance activities.
Manage strategic planning and development of activities for validation function, including compliance, capacity, timelines, and directions.
Establish, generate, and maintain Validation procedures in compliance with company and industry standards.
Collaborate with QA and Manufacturing and engineering teams to maintain the validation program quality systems.

**About you**:
Degree in Biotechnology/ Chemical Engineering/ Bioengineering/ Life Sciences or related studies.
Minimum of 8 years in an validation and engineering or quality role in a cGMP related role with at least 2 years in a people management role.
Highly adaptable and capable of performing in a dynamic working environment.
Knowledgeable on cGMP manufacturing of investigational products and their associated requirements. Able to ensure validation activities for the manufacturing of products in preclinical and clinical trials (Phase 1, 2, 3) are performed in a manner appropriate to the current stage of the product lifecycle.
Are you a good fit for a Commissioning Qualification Validation Manager? Get in touch with us today.

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