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QA Officer

1 month ago

Brisbane, Australia Thermo Fisher Scientific Full time

At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

**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.

**Key Responsibilities**:
Performing real time 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 review and approval of Process Validation / Equipment Validation documents for example Microbial Mapping validation protocols, resin re-use protocols, cleaning validation protocols, new equipment, etc

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 rejects, 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

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, tackle complex scientific challenges, drive technological innovation and support patients in need.

StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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