Sypharma is an Australian specialty contract manufacturing group, motivated by a commitment to creating healthier futures. Since 2005 we've developed and manufactured therapeutic goods, veterinary products, and specialty consumer products. We're a trusted partner and provider of biotechnology healthcare products in Australia and we partner to contract manufacture products for local and international markets.
We are currently seeking a QA Associate to join our team in Dandenong South. Reporting to the Senior QA Associate, the successful applicant must have a (1-3) years' experience working in a QA environment in the pharmaceutical sector.
This is a fantastic role for someone within a pharmaceutical environment and is a great opportunity for career enhancement and skill set development or if you are looking at the next step in your career.
About the role:
Reporting to the Head of Quality and Regulatory Affairs, you will be a key representative in the compliance of a pharmaceutical facility located in Melbourne. Additionally, you will support compliance activities related to various projects.
Your main responsibilities will include, but are not limited to:
* Maintenance of the QMS – internal audits, risk assessment, change control, CAPA, Deviations.
* Trending and investigational report writing.
* Performing PQRs.
* Assisting in management reviews.
* General maintenance of procedures (creation, review or approval) – SOPs, WIs.
* Overseeing training and vendor assurance management.
* Assisting in regulatory Audits.
* Liaise with all relevant (Operations, R&D, etc) departments regarding quality related issues.
* Support the execution of the qualification and validation program for the facility.
* Work collaboratively with stakeholders for projects allocated including R&D, Validation, Engineering, Manufacturing, QA and QC staff and others to ensure the activities are planned and delivered in an efficient timeframe.
Skills and experience:
* A degree in a relevant science, with at least (1 - 3) years experience in at least one of: manufacturing under GMP, Regulatory Affairs, Quality Assurance or relevant process development
* In-depth understanding of GMP requirements in the pharmaceutical industry and previous production, Quality or R&D experience within the pharmaceutical industry including qualification and validation principles and applications
* Good interpersonal, negotiation and influencing skills
* Good analytical and problem solving skills
* Ability to work well independently and to self-motivate
* Well-developed organizational and time management skills
If this sound like you, please apply.