(Snr) Quality and Compliance Specialist
Cell Therapies is a unique enterprise that develops and manufactures innovative immune therapies and regenerative medicine products for patients, researchers and clinical trial sponsors locally and internationally. Established in 2003, Cell Therapies Pty Ltd is acknowledged as a leader in the manufacture and supply of human cell and tissue therapies in the Pan-Asian region. We are building the supply chain capabilities, infrastructure and systems to bring these ground breaking treatments to Australian and Asian patients.
We are seeking a motivated (Snr) Quality and Compliance Specialist to perform a critical role in the production of clinical and commercial cellular therapy products in compliance with the Australian Code of Good Manufacturing Practice for human blood and blood components, human tissues and human cellular therapy products.
This is a full-time position located at our new state of the art Melbourne facility located at the Peter MacCallum Cancer Centre on the edge of the CBD in Australia’s most dynamic biomedical precinct.
Key activities for this role include:
- Working with key stakeholders, lead deviation & CAPA investigations and ensure closure by set timelines
- Provide guidance and oversight for change control activities
- Formulate and implement remediation plans
- Act as Quality SME on project teams and ensure projects are delivered per the appropriate level of GMP relevant to the development phase
- Perform internal and external audits and manage any associated close out actions
- Actively participate in the risk management program
- Validation protocol & report review and approval
- Administration of the electronic quality management system (Q-Pulse)
- Document creation, review and approval
- Document control and issuing of batch records
- Lead continuous improvement initiatives
- Manufacturing batch record review for complex biological products
- Supplier and vendor contract oversight
- Collating, monitoring and reporting key quality indicators
The ideal candidate has the following skills/experience:
- Previous experience working in a GMP quality environment within the cell processing industry
- Practical understanding of the requirements of the relevant codes of Good Manufacturing Practice (e.g. TGA, PIC/S, and EMA) as they are applied within a biological manufacturing setting
- Track record of efficient management and resolution of quality processes using consultation and SME input to ensure appropriateness of decisions
- Excellent communication skills
- Ability to operate with a high degree of independence
- Demonstrated problem solving and decision making skills
- A tertiary qualification in a relevant scientific discipline
Additional desirable skills are:
- Experience working in an ISO14644 classified environment for a sterile or aseptic process
- Experience working in a medical laboratory environment
- Understanding of product development
- Understanding of quality control methodology
This is a rare chance to become involved in the clinical production of novel and cutting edge therapies.
Salary offered will be commensurate with skills and experience and industry standards.
Applications, including a CV and covering letter addressing the key requirements of the role, should be submitted via “Apply for this job” through Seek (Snr) Quality and Compliance Specialist
Applications for this position close on Friday 26 May, 2017. Interviews may be scheduled prior to the closing date so early application is encouraged.
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