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Senior Quality Assurance Associate

Tripak Pharmaceuticals -
Brisbane QLD

Apply Now

Job Details

Permanent | Full-time | Contract
8 hours ago

Qualifications

Microsoft Powerpoint
Microsoft Word
Microsoft Excel
Computer skills
Communication skills
FDA regulations

Full Job Description

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 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.

Apply Now

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