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Job Title: Quality Assurance Officer
Reports to: Team Leader, Q on the floor
Group / Division: Pharmaceutical Services Group (PSG)/ Drug Substance Division (DSD)
Career Band: 4
Job Family: Operations (OPS)
Job Sub Family: Quality Assurance (QAOP)
Job Code: OPS.QAOP.P04
Job Track: Professional
Position Location: Brisbane, Australia
Position Summary:
The Brisbane site is a multi-product biopharmaceutical site with development and manufacturing facilities for biopharmaceutical products for clinical trials (Phase I, II and III) as well as commercial products. Manufacturing of biopharmaceutical products is required to be in compliance with regulatory requirements as defined by TGA, FDA, EMEA, ICH and other applicable regulatory agencies. The Quality Assurance group is responsible for ensuring compliance to the applicable cGMP requirements.
This candidate will join our outstanding Quality-on-the-floor program and assist Operations and QC with real time quality support. If this sounds like you, we'd love to hear from you!
Key Responsibilities:
Performing batch record reviews. This includes reviewing protocols during the manufacturing process as well as post production to ensure the quality of the product.
Performing routine audits of logbooks used in the operations/QC areas for completeness and cGMP compliance.
Performing final QA review and approval of batch related documentation
Active participant in deviation investigations
QA Approval of quality records including but not limited to; Deviations, Out Of Specifications, CAPAs, Audit findings etc.
Review and approval of QA controlled documents within the Quality Management System.
Supports compliance to systems timeframes for raising, processing or performing associated tasks (i.e. Change Control actions, DR investigations, processing CAPAs)
Issuing protocols as required to other departments
Perform quality functions including vial thaw, drug substance shipping as required
Updating SOP's and other documents to meet current regulatory and corporate standards
Serving as a resource to the operational areas on quality related issues.
Identification of continual improvement opportunities
Conducting Internal Audits
Participating in Risk Assessments
Any other legitimate duties requested by QA Manager.
Frequent Contacts:
Internal: Operations (USP, DSP, MBP), Warehouse, Validation, Engineering, Process Engineering, Quality Control
External: Clients and Regulatory Agencies
Minimum Requirements/Qualifications:
Qualifications & Experience
- Tertiary Academic level in a relevant field (Biotechnology, Biochemistry, Microbiology, Chemistry, Pharmacology, or equivalent).
- Minimum 3 years of experience in a GMP regulated environment
- Preferably, minimum 1 year of experience in Quality Assurance in a GMP regulated environment
Skills & Attributes
- Knowledge of pharmaceutical cGMP quality systems and international cGMP regulations and guidelines.
- Strong communication skills
- Strong written, verbal and presentation skills
Other Job Requirements:
- Adhere to EHS policies and procedures and ensure a safe and healthy workplace environment
- Ensure hazardous conditions, hazardous actions, incidents and near-miss incidents are reported.
- Not knowingly pollute the environment
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