Validation Specialist

2 weeks ago

Melbourne, Australia Icon Group Full time

**Pharmaceutical Compounding**

**Melbourne**

**Full Time**

**Slade Health**

**Validation Specialist - Slade Health**
- Wonderful Opportunity to Develop Your Career in a Far-Reaching Organisation
- Fantastic Position in a Collaborative Team
- Full-Time (Mon-Fri 76-hour f/n)
- Permanent Position - Mt Kuring-gai (Sydney) or Mt Waverley (Melbourne) Location
- On-site role with occasional travel as required to other Slade Heath Compounding Facilities

Slade Health provides a complete range of sterile compounding services, including Chemotherapy, Analgesics, Antibiotics and TPN compounding. With facilities based in Queensland, Victoria, New South Wales, South Australia and New Zealand, quality is embedded into every stage of the compounding process.

**Part of something bigger**
Be part of Icon Group, Australia’s largest dedicated cancer care provider, with a global presence. The Group is built on a strong but simple vision - to deliver the best care possible, to as many people as possible, as close to home as possible.

**About the Role**:
We are currently seeking a tertiary qualified Validation Specialist to join our innovative and dynamic team. The role would preferably be based in either of our Mt Kuring-gai NSW or Mt Waverley VIC site.

Reporting to the Validation Manager, this position of Validation Specialist will support the ongoing validation program to ensure that the validated state of facilities, utilities, equipment, IT infrastructure, devices and the compounding process are maintained at all times.

This role is offered on a permanent full-time basis working 76 hours per fortnight (Monday - Friday).

**Key Responsibilities**:

- Coordinate the activities of assigned validation and contract personnel to ensure the quality of completed work.
- Manage the development, implementation and execution of validation protocols and procedures.
- Liaise with suppliers/vendors to address documentation and compliance issues.
- Working closely with multiple departments to ensure all activities are completed.
- Prepare documentation and associated data for regulatory submissions/audits and present validations to regulatory authorities during inspections.
- Manage execution of validation protocols.
- Preparation of validation reports.
- Maintain the validated state through proper change management processes.
- Ensure filing and documentation is up-to-date and is compliant with standard processes and formats.

**What we are looking for**:

- Bachelor’s Degree in a scientific or related discipline.
- Five years’ experience in a similar or related position (essential).
- Experience in developing, executing, monitoring, and managing validation activities,
- Experience in process validation will be highly regarded.
- Demonstrated knowledge of qualification and validation and risk analysis requirements within the pharmaceutical industry.
- Strong technical skills, time management skills and a solution-based approach.
- Ability to work autonomously.
- Excellent communication and interpersonal skills
- Demonstrated excellent verbal and written communication skills in successfully dealing with customers and difficult situations.
- Demonstrated report writing skills.

**How to Apply**:

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