Computer Systems Validation Associate

2 weeks ago

Melbourne, Australia Icon Group Full time

**Pharmaceutical Compounding**

**Melbourne**

**Full Time**

**Slade Health**

**Computer Systems Validation Associate - Slade Health**
- Join a Dynamic and Supportive Work Environment
- Work in a Fast-Paced Environment that Demonstrates Compassionate, Genuine Care for Patients and Customers
- Permanent Full-Time Position - Located at any of our existing Australian sites in Mt Waverley (VIC), Mt Kuring-gai (NSW), Geebung (QLD) or Woodville (SA) Location

**About Slade**:
Slade Health is a national provider of aseptically compounded chemotherapy, antibiotics and analgesic medicines. It operates TGA Licensed manufacturing facilities in Victoria, Queensland, New South Wales, South Australia and New Zealand.

**About the Role**:
The role of Computer Systems Validation Associate is primarily responsible for assisting the Computer Systems Validation and Reporting Specialist to implement the Slade Health computer systems validation program which includes customer facing, operational, quality and facility focussed systems.

**Key Responsibilities**:
In this position you will be involved in:

- Assisting with the development, implementation and execution for validation protocols and procedures to ensure computer systems validations meet appropriate regulatory agency validation requirements and internal company standards.
- Maintaining and update operational systems to ensure that computer systems validations are performed in a timely manner.
- Assisting with the preparation of User Requirements and review design information.
- Assisting with the design and preparation of validation protocols, TMX and summary reports.
- Co-ordinating and perform computer systems validation projects as per approved protocols.
- Reviewing Executed protocols and route for approvals
- Preparing Validation and Technical reports as required.

**What we are looking for**:

- Bachelor’s Degree, preferably in a science related discipline (e.g. pharmacy, IT, science, engineering) or equivalent experience
- Experience in developing, executing, monitoring, and managing computer systems validation activities in GMP regulated industry (ideally following GAMP 5 Guidelines).
- Experience in within the GMP manufacturing industry is desirable.
- Demonstrated technical, protocol and report writing skills.
- Proven time management skills, with demonstrated ability to prioritise workload to meet deadlines, and forward plan to ensure work and information is complete and commitments are fulfilled.
- Advanced computer literacy (particularly Word, Excel, Outlook) combined with sound keyboarding skills.
- Understanding of aseptic compounding processes and flows is highly desirable.

This role is offered on a permanent full-time basis working 76 hours per fortnight. Hours are typically 9am - 5:30pm but we are flexible as long as the 76 hours per fortnight is met.

**How to Apply**:
**COVID Health Requirement

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