Quality Assurance - Deviations - Pharmaceuticals

Industry:

Pharmaceutical (Good Job Security in a Pandemic)

Location:

South Eastern Suburbs (near Clayton)

Hours per week:

38 hours per week with the span of those hours to be worked between 8:30 am to 6:00 pm, Monday to Friday.

Shifts available:

Day

Employment Conditions:

Permanent

The goal of the role:

To ensure that activities undertaken by our client are in accordance with current regulations, internal procedures and any agreed customer requirements. All QA production activities with a focus on incident deviations and rework requests.

Day-to-day role:

• Keeping up to date with regulations, TGA licence conditions, codes of practices, and/or standards which are associated with processes.

• Facilitate investigations in the event of a product and/or quality system failure, in liaison with relevant departments and subject matter experts

• Ensure that investigations are of sufficient detail.

• Ensure that the root causes are identified (or sufficient evidence is available that they are not identifiable).

• Ensure that actions are appropriate and authorised as required to address the failure and the root cause of the failure.

• Provide reports as requested of the trends that are observed and maintain an overview of the system performance and repeat failures.

• Write and review SOPs where required.

• Liaise with QA Manager (or delegate) in administering the deviation system and rework instructions.

• Other tasks as required by the QA Manager.

• Identify opportunities for improvement in the way that QA functions.

• Develop and maintain a strong knowledge of current and appropriate regulations, standards and best practice for the benefit of our client and their customers. Process improvements for quality systems to improve efficacy and reduce costs. Maintain a good understanding of customer requirements and in turn implement these where applicable into systems via suitable mechanisms.

• Report to the Senior Quality Assurance Coordinator. Collaborate with personnel as well as customers and regulatory bodies and present complex information to influence outcomes.

Must have:

• Be a proactive and collaborative team member with at least three years’ experience in a technical environment (industry, university, etc.), with an ability to quickly learn the relevant regulations and standards.

• Strong working experience of Quality Assurance roles in a regulated GMP environment. An ability to communicate with employees at all levels.

• PR / AU or NZ citizenship

If this sounds like your next career move please apply via Seek and include a copy of your resume and cover letter.

IMPORTANT: It is a requirement of all our jobs that you have a PR or AU/NZ Citizenship. A work visa is not sufficient as all our jobs are permanent. Please do not apply if you do not meet these requirements.