Senior Quality Compliance Associate

Sypharma | Dandenong South, Melbourne

Sypharma is an Australian specialty contract manufacturing group, motivated by a commitment to creating healthier futures. Since 2005 we've developed and manufactured therapeutic goods, veterinary products, and specialty consumer products. We're a trusted partner and provider of biotechnology healthcare products in Australia, and we partner to contract manufacture products for local and international markets.

We are currently seeking a Senior Quality Compliance Associate – Release to join our team in Dandenong South. Reporting to the Head of Quality and Regulatory Affairs, the successful applicant will have 3-5+ years' experience working in a Quality Compliance environment within the pharmaceutical sector and will bring a strong working knowledge of GMP associated with QC testing and release of raw materials and finished product  as a senior, hands-on role within our Quality team.

This is an excellent opportunity for an experienced Quality Compliance and QC professional looking to step up into a role with greater autonomy, ownership of key quality processes, and the chance to mentor junior team members within a growing pharmaceutical manufacturing environment.

About the Role

Reporting to the Head of Quality and Regulatory Affairs, you will be a senior representative in the compliance of our pharmaceutical facility, taking a lead role in maintaining and continuously improving our Quality Management System while supervising the QC function and supporting and mentoring junior QA & QC staff, including the QA Associate.

Your main responsibilities will include, but are not limited to:

• Leading and supervising the QC laboratory (Chemistry & Micro) and ensuring that all required testing is completed by the required timelines

• Conducting the release of finished products and raw materials by Liaising with production and ensuring the release of raw materials required for the manufacturing process in an agreed an timely process

• Supervising and approving the preparation of raw material and finished product specifications and ensuring that all specifications are compliant.

• Working collaboratively with stakeholders across R&D, Validation, Engineering, Manufacturing, QA and QC to ensure projects are planned and delivered efficiently.

• Representing the quality function in project meetings

·       Supporting and reviewing the execution of the facility's qualification and validation program by conducting any required testing

• Leading and hosting regulatory audits and inspections as required

• Supporting and reviewing the execution of the facility's qualification and validation program.

• Overseeing training programs and vendor assurance management.

• Mentoring and providing guidance to the QA Associate and other junior QA team members.

• 
  

• 
  

Skills and Experience

• A degree in a relevant science discipline, with at least 3-5 years' experience in manufacturing under GMP, Regulatory Affairs, Quality Assurance or relevant process development.

• Strong, demonstrated understanding of GMP compliance relating to raw materials and finished product testing requirements in the pharmaceutical industry, including qualification and validation principles and their practical application.

• Proven experience leading or hosting regulatory audits and inspections.

• Demonstrated experience mentoring or supporting junior team members.

• Strong interpersonal, negotiation and influencing skills.

• Excellent analytical and problem-solving skills, with the ability to lead complex investigations.

• Ability to work autonomously, prioritise effectively, and self-motivate.

• Well-developed organisational and time management skills.