Quality Assurance Specialist

2 days ago

Melbourne, Australia Pettit Pharma & Device Search Full time

Office based role for first 6-months, then 1-2 days a week from home
- Parking on site in South-East Melbourne, 20kms from CBD
- Amazing benefits working here, great team and culture, be valued

WHO IS THE COMPANY YOU WOULD BE JOINING?
- This global healthcare organisation is committed to making a meaningful impact on the health of Australians, in particular children.
- As a team this company leads the education of Health Care Professionals and the general public to increase awareness of what they do.

THE BENEFITS TO YOU
- A family friendly, collaborative culture where everyone is working towards a common goal. Be appreciated and valued.
- An extremely rewarding role that makes a huge difference to people’s lives.
- No competitors in Australia, cutting-edge innovation in healthcare.

WHAT YOU WILL LEAD AND MANAGE IN THIS ROLE
- This Life Science Quality Assurance Specialist position, sits at a senior-level and reports to the Life Science Quality Manager. The role will own Quality System(s) working with stakeholders in facilitating meetings, providing data from tracking and trending, leading quality and continuous improvements.
- The role will have the responsibility to train the organisation on the Quality System(s), as well as mentoring Quality team members. The individual will help drive change that will remediate the risks to internal and external customers.
- The position is primarily responsible for establishing, developing, implementing, maintaining and improving Quality System processes and programs to include: Quality Event Reporting (Deviations, Nonconformance, Change Management, CAPA, Complaint), Document Control Program, Supplier Qualification, Validations, and Product Transfer.
- You will foster cross-functional collaboration and partnerships, lead by positive influence, maintain a high level of integrity, and possess a strong continuous improvement mindset.
- You will own the Quality Management System and be responsible for Document Control, Change Management, Deviations & Nonconformance, Quality Events, CAPA, Audit, Validations, Quality Metrics, etc.
- You will facilitate meetings, provide system visibility, communicate status, and facilitate closure of aging items.

WHAT YOU WILL NEED TO SECURE THIS POSITION
- University degree in science, nursing or similar or equivalent work experience in Quality with a minimum of 4 years’ experience in QA in the pharmaceutical or medical device industries.
- The key to securing this role is a comprehensive understanding of and experience in GMP, TGA requirements, GAPA, Deviations and ideally you will be certified in internal auditing.
- Knowledge of Master Control, or similar eQMS a plus.
- Excellent English written and verbal communication with good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals.
- Ability to check information, pick up inconsistencies and mistakes and make detailed comparisons between similar sources. Attention to detail is key to succeed in this role.
- Excellent critical analytical skills - ability to find root cause of why an issue occurred.

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