Company Overview:

Proclinical is proud to be partnered with our client, a globally recognized leader in biopharmaceuticals, dedicated to treating and preventing human medical conditions. With their unwavering commitment to innovation, research, and medicines with advanced manufacturing capabilities, they are drivers in securing population health and wellbeing.

The Tullamarine site is a greenfield $800 million project to establish a state of the art influenza vaccine and antivenom manufacturing site, the only one of it's kind in the southern hemisphere.

Overview:

Reporting to the Manager QA Frontline, the 2 x Validation Associate are responsible for all activities involving quality assurance and compliance with applicable regulatory requirements; supporting the project team to provide advice and resolve quality issues, ensuring the site is compliant with a heavy emphasis on QA Validation work, supporting Engineering runs, and process qualification activities.

Team Size: 15 people (5 managers, plus 10 others)

Duration: 18 weeks approx. Too early to say regarding possible extension

Start Date: ASAP

Hours: Standard Mon to Fri, with possible weekend work and afternoon shift

Capacity: All on-site

Location: Tullamarine, VIC

WHV: Yes, open to WHV candidates

Role:

• Quality assurance position
• Issues and change control
• Qualification and review of approval of protocols
• Attending daily meetings to represent Quality at operational meetings
• Escalation of issues
• Problem solving – root cause analysis

Requirements:

• 1-3+ years experience in a similar role, (3 + years in QA and 1+ QA validation ideal)
• Experience in current Good Manufacturing Practices (cGMP) principles
• Experience in QA validation to support qualification activities for manufacturing.
• Experience in a role with problem solving, creative thinking, and effective decision-making.
• Experience in a role requiring initiative, autonomy, and learning agility.
• Experience communicating complex information both verbally and in writing.
• The ability to work within a team environment and contribute to the goals of the team and the business.
• Flexibility to work additional hours as required by the role

How to Apply

If this opportunity aligns with your experience and career goals, please click ‘Apply Now’ to submit your application.

For a confidential discussion or to learn more about this role, please contact Pamela Phoumavong via email at [email protected] or call 02 9054 7411.

About Proclinical

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.