Validation Specialist

2 weeks ago

Sydney, Australia Icon Group Full time

**Pharmaceutical Compounding**

**Sydney**

**Full Time**

**Slade Health**

**Validation Specialist - Slade Health - Sydney**
- 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 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 in Singapore, Mainland China, Hong Kong and New Zealand. 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.

**Here’s why our people choose us**

**Purpose, at Pace**: We remain focused on continually expanding our services and making them accessible to more people across Australia and internationally.

**Impact, at Scale**: We have a global reach and are growing every day. Here you’ll know your work is making a difference.

**Connection, at Heart**: Our work isn’t easy but it’s extremely important. Our secret ingredient is our incredible, connected, and talented people. And their secret ingredient is each other.

**Opportunity, at Hand**: We’re continually innovating. Every week brings changes, growth and new opportunities.

**About the Role**:
Reporting to the Validation Manager, this position of Validation Associate will support the 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
- Interface with suppliers/vendors to address documentation and compliance issues.
- 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.
- Proven time management skills
- Demonstrated ability to effectively and independently solve problems
- 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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