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Form of workTripak Pharmaceuticals is a leading Brisbane based Contract Manufacturer of over 700 personal care products.
Due to continuing strong growth, there is an opportunity 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.
