05 Aug
|
Martin and Pleasance
|
Queensland
05 Aug
Martin and Pleasance
Queensland
Martin & Pleasance is a leading Australian natural medicine company based in Port Melbourne, Victoria. With a strong reputation built on quality, innovation, and integrity, our products are widely distributed across pharmacies and health food stores throughout Australia and New Zealand, as well as international markets including the UK, US, Canada, and Asia.
Our portfolio includes trusted and well-known brands such as Rest & Quiet, Harmony, Schuessler Tissue Salts, Organic Formulations, and Vital All-in-One.
Who we are looking for
We are seeking a capable QA Compliance Officer / Senior QA Officer to join our Quality team at our Loganholme manufacturing facility.
This is a broad quality systems role responsible for supporting the effective operation, maintenance and continual improvement of the Martin & Pleasance Pharmaceutical Quality System. The role is suited to someone with strong GMP knowledge, practical QA experience and the ability to manage quality-system activities through to completion.
Reporting to the Quality Manager, you will coordinate, monitor and support key GMP compliance activities including validation, stability, Product Quality Reviews, deviations, CAPA, change control, audits, documentation, quality risk management, calibration, preventative maintenance, pest control, water system monitoring and quality-system trending.
What you'll be doing
- Maintain oversight of assigned Pharmaceutical Quality System elements and GMP registers.
- Monitor due dates, overdue actions, quality trends and escalation requirements.
- Manage and maintain the Validation Master Plan, validation register, validation schedule and related validation documentation.
- Coordinate the stability program, including study initiation, sample schedules, result review, OOS/OOT escalation, trend review and record maintenance.
- Perform, coordinate and support Product Quality Reviews.
- Review and support investigations for deviations, non-conformances, OOS/OOT results, complaints, CAPAs and change controls.
- Support internal and external audits, including audit preparation, evidence collation, observation tracking, CAPA responses and effectiveness verification.
- Review and update GMP documentation including SOPs, forms, registers and quality records.
- Support oversight of recurring GMP control programs, including calibration, balance and pipette checks, preventative maintenance, pest control, cleaning/GMP housekeeping checks and water system records.
- Support release-for-supply activities as required, including acting as an authorised person or release delegate where appropriately trained and authorised.
- Support GMP training and help ensure staff follow established quality processes.
- Support supplier and contractor quality performance review, including external laboratories, calibration/maintenance providers and pest-control service providers.
- Support maintenance of regulatory licences, certifications and compliance evidence for TGA, ACO, JAS,
COSMOS and other applicable schemes.
- Identify continuous improvement opportunities and support the Quality Manager in implementing quality-system improvements.
What skills and experience you'll bring to this role
This role would suit someone who enjoys working in a hands-on manufacturing environment where systems, documentation and processes are continuing to mature.
- Minimum 5 years' experience in QA, QC, quality systems or compliance within a regulated industry.
- Solid working understanding of TGA GMP requirements.
- Experience in pharmaceutical, complementary medicine, food, cosmetic, medical device or natural products manufacturing would be highly regarded.
- Experience with validation, stability, PQR/APR, CAPA, change control, deviations, OOS/OOT, complaints or audit systems.
- Ability to review investigations and assess root cause, product quality impact, risk, CAPA suitability and effectiveness.
- Ability to review and trend quality-system data.
- Strong written communication skills and the ability to prepare clear reports, procedures, risk assessments and quality summaries.
- Experience using or ability to interpret BP, Ph. Eur., USP or other compendial references is required.
- Understanding of basic wet and dry chemical testing methodologies, UV/VIS/FTIR spectroscopy would be advantageous.
- Good computer literacy, including Microsoft Word, Excel and Outlook. Strong Excel capability will be well regarded.
- Tertiary qualification in Science, Quality, Pharmaceutical Science, Chemistry or another relevant discipline, or equivalent industry experience.
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📌 Compliance Officer / Senior QA Officer (Queensland)
🏢 Martin and Pleasance
📍 Queensland