Tripak Pharmaceuticals Pty Ltd

Capalaba, Brisbane QLD

Full time

Tripak Pharmaceuticals is a leading Brisbane based Contract Manufacturer of over 700 personal care products.

Due to continuing strong growth, there is an prospect to join our talented Quality team in a permanent position. Reporting to the QA Manager, you will be responsible for:

- Maintaining and continuous improvement of the QMS, creating QMS documentation, ensuring appropriate documentation is in place, and identifying compliance gaps.
- Reviewing of GMP and non-GMP records, e.g., those associated with training, materials, calibration, manufacture.
- Reviewing and approving batch documentation and batch release.
- Assist in vendor assurance and supplier management, including review of completed questionnaires, performing of supplier risks assessments, and evaluation of new suppliers.
- Training material development and training delivery in GMP and areas of expertise, ensuring relevant personnel are trained in relevant procedures and regulatory requirements.
- Reviewing and approving change controls, CAPAs, Non-conformances, and deviations. Working with other departments to ensure appropriate investigations are conducted and closure in a timely manner.
- Performing Quality inspections, testing, labelling, and disposition of incoming materials and verifying correct storage.
- Performing and reporting on internal audits and assisting with audits by external parties
- Perform additional duties as required.

Qualifications

The role requires a hands-on approach, a high level of initiative, and meticulous attention to detail. Further requirements are:

- Minimum 5 years Quality department experience within the pharmaceutical/biotech industry.




- Sound knowledge of and experience in GMP for medicinal products, regulations, and compliance in one of the following regulatory frameworks: TGA, FDA, EMA.
- Knowledge and experience in validation, such as validation of processes, test methods, equipment, facility, computer systems, cleaning, utilities.
- A tertiary qualification in an appropriate discipline, e.g., completion of a science or biotechnology degree.
- Demonstrated problem-solving and critical thinking skills, being task-oriented with a solution-focussed approach.
- Advanced computer skills with proficiency in MS applications (Word, Excel, PowerPoint) and Adobe Professional, and an ability to learn other computer-based systems.
- Results driven, and comfortable working in a fast-paced, dynamic environment.
- Willingness to learn and to seek answers to problems and issues and propose solutions.
- Effectively working with others to ensure the business needs and timelines are met.
- Demonstrated ability for self-managing, planning, organising, prioritising, and multi-tasking independently and as part of a cross-functional team. Manage priorities within prescribed timeframes.
- Proven interpersonal skills and excellent communication skills (verbal/written/presentation). Ability to work collaboratively with internal and external stakeholders.
- A proactive approach to Quality system improvement and management through continuous improvement methodologies.

If you are passionate about TGA/GMP level manufacturing and have the enthusiasm, competency, and desire to work in a company that encourages high performers, then please send us your resume and cover letter.

Be assured that all applicants will be treated in strictest confidence.

📌 Senior Quality Assurance Associate (Brisbane)
🏢 Tripak Pharmaceuticals
📍 Brisbane