Address
Form of workIMMEDIATE START
Immediate start is available
SALARY
A competitive remuneration package includes:
1 x full time permanent position
- Base Salary + Bonus + Superannuation
- Free Car Park for all staff on site
- Office perks including office massage & stocked lunch room
- Strong company culture
ABOUT PARNELL
Over the last 60 years, Parnell has become a leading global veterinary pharmaceutical business marketing products in 14 countries. We have built a fully integrated animal health platform with a strong track record in research & development, we operate an FDA and APVMA accredited sterile manufacturing facility and offer unique digital technology platforms that integrate with our innovative products to offer veterinarians and animal owners superior solutions to their animal health needs.
THE POSITION
As a Senior QA Associate, you will perform an important role in the maintenance and compliance of the Parnell Quality Management Systems applicable to the manufacture of products for all relevant regulatory jurisdictions (US FDA, APVMA).
ABOUT YOU
We will consider candidates that demonstrate the following:
- An individual contributor who demonstrates a culture of execution
- Team player who is both focused on success and has ability to work independently and own their role
- Advanced written and verbal communication skills and a strong aptitude to prioritise your work
- Strong adherence to Continuous Improvement and solutions based thinking
RESPONSIBILITIES & DUTIES
- Contribute to the development and maintenance of cGMP compliance applicable to all relevant regulatory jurisdictions.
- Participate or be a lead auditor for internal or external audits.
- Participate in media fill observation and inspections and in any recall actions.
- Coordinate the Annual Product Quality Reports, Annual Quality System Reports, asset management, retention sample inspection, artwork and change control programs including review of change controls and other documents.
- Coordinate and complete out-of-specification investigations, deviations, incubator out of limits, complaints, CAPA investigations and trend data analysis as required.
- Prepare and review annual product quality reports and annual quality system reviews.
- Provide and track real time reporting of the major QMS programs as required. Manage the input of QMS data and report on a regular basis to management
- Provide supporting QA functions in material release, product release, validation, maintenance, cleaning/sanitation and environmental/system monitoring programs as required.
- Provide backup function for Quality Document Management System (DMS) including being administrator of ZenQMS, batch issuance, finished product release including batch record review and trend data analysis, material release of ancillary and packaging materials, and other tasks as required.
WORK EXPERIENCE & SKILLS
- Bachelor or higher degree in Science or a related discipline
- 3+ years prior QA experience in a GMP/Pharmaceutical manufacturing environment
- Chemistry/QC laboratory background highly regarded
- Pharmaceutical experience in a sterile manufacturing company highly regarded
