Quality Assurance Professional

This is a Part Time position based in Sydney.

We are seeking an experienced Quality Assurance professional to join our team as a QA Associate. In this role, you will be responsible for the quality assurance supervision of third-party manufacturers, packers, and storage facilities.

• Performing Perrigo product release, auditing, addressing customer complaints and deviations associated with third-party manufacturers.
• Establish relationships with third-party suppliers to enhance product quality and manufacturing effectiveness and efficiency.
• Maintaining an effective working relationship with all staff and third-party contractor personnel.

• Identifying and assessing new contractors in conjunction with relevant departments.
• Preparing and maintaining GMP / Quality agreements with all contractors to ensure all responsibilities are clearly stated, all GMP requirements are specified, and that Perrigo's interests are protected from a quality, GMP and commercial perspective where required.
• Monitoring contract manufacturers' quality indicators and performance to identify potential problems before they affect products.
• Ensuring greater than 95% compliance with training requirements. Attending all training sessions as determined by Manager.
• Encouraging a quality culture with all staff and acting in accordance with quality standards and values.
• Ensuring relevant standards are complied with and that changes to the Perrigo Quality Management System within the scope of the department are in line with internal and external requirements.
• Performing Release for Distribution for Products manufactured by Contractors and other Perrigo sites where specified in GMP / Quality agreements in accordance with the products Marketing Authorisation and company procedures.
• Providing cGMP / ISO training for Perrigo personnel and Contractors.
• Providing on-the-job training on specific job functions, processes or procedures as required.
• Reviewing deviations from third-party manufacturers to ensure the investigation has adequately determined; the scope, assessed the impact on the product and the root cause. Based on the deviation's investigation ensuring agreement with the contract manufacturer's product disposition decision. Where the deviation investigation is not adequate, or the disposition decision is not appropriate working with Contractors Quality representative to reach a suitable outcome to the situation.
• Reviewing corrective actions proposed by the Contractor to ensure they are adequate. Tracking all corrective and preventative actions approved to ensure timely closure.
• Investigating customer complaints, determining suitable responses and associated corrective and preventative actions as required.
• Assessing Contractor Change controls to assess the appropriateness of the change, impact on marketing authorisation, adequacy of risk assessments and implementation plan of the change control.
• Reviewing the following quality documents for adequacy and completeness: Master Batch Records, Product Specifications, Product Test Procedures, Validation Protocols and Reports, Stability Protocols and Reports, Periodic Product Quality Reviews, Change Controls.
• Performing internal and external audits as specified by QA Manager to assess compliance to relevant industry standards, company policies and procedures and contractual obligations.

• Tertiary qualifications in science or engineering.
• 5-7 years' experience in the pharmaceutical or similar manufacturing industry.
• Experience in the development, operation and maintenance of relevant quality assurance management systems.
• Understanding of chemical and microbiological test processes used in the pharmaceutical industry.
• Understanding of Marketing Authorization process in Australia and New Zealand.
• The ability to create meaningful relationships with a broad range of people.
• Proficient in Microsoft Outlook, Excel, Word, PowerPoint and able to learn new software applications.

We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.

We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging. Join us on our journey as we evolve to win in self-care.