1. General Job information
Job title: QA Officer
Department: Quality Assurance
Business Group/Unit: Patheon Biologics Australia
Service Group/Unit: DPx
Location: Brisbane, Australia
2. Position in the organisation
Reports to: QA Operations Manager
Direct reports: N/A
Indirect reports: N/A
Organisation Chart: Attachment 1
3. Purpose of the job
Manufacturing of biopharmaceutical products is required to be in compliance with international quality requirements as defined by TGA, FDA, EMEA, ICH and other applicable regulators.
To achieve and maintain compliance with all relevant national and international regulatory requirements.
The Quality Assurance Group is responsible for development, implementation, updating and auditing the documented Quality System and for compliance against the applicable cGMP requirements.
4. Job Context
The Brisbane site is a multi-product biopharmaceutical site with development and manufacturing facilities for pharmaceutical products for clinical trials (Phase I, II and III) as well as commercial products.
This type of facility has to comply with rules and regulations of cGMP set by countries health and welfare ministries and with internationally harmonized guidelines that give guidance with implementing these rules and regulations.
Compliance with these rules, regulations and guidelines is essential for maintaining the TGA Manufacturing license, as well as meeting GMP compliance of other international regulatory bodies. Compliance should be achieved in an effective and efficient manner to ensure competitiveness of the site.
Responsibilities relevant to the position are outlined in SOP's, WI's and other relevant controlled documents.
5. Job Content
Key Areas of Accountability / Responsibility
Drive compliance to the Quality Management System, by
Performing real time batch record or analytical record reviews throughout the designated shift. This includes auditing executed sections of protocols, post production and during the manufacturing process to ensure quality of the product in process. Items audited during this process include documentation and overall cGMP compliance issues. Performing routine audits of logbooks used in the operations/QC areas for completeness and cGMP compliance. Performing final QA review of batch related documentation as required. Assisting operations/QC with initial review of process, analysis and facility related issues, participates in investigations and advises when and how to complete Deviation Reports (DRs) and appropriate forms, e.g. Remark Forms (RFs), as required. Approving Trackwise record (Deviations, OOS, CAPA, Audit findings) when requested. Assisting with the review of QA controlled documents to ensure the compliance with review periods and ensure the documents reflect current practices 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, shipping as required Updating SOP’s and other documents to meet current regulatory and corporate standards Serving as a resource to the operations areas on quality related issues. Advocates EH&S compliance Identification of continual improvement opportunities Any other legitimate duties requested by QA Manager.
6. Complexity of the job
The Patheon Biologics Brisbane site manufactures many products for several stages of clinical trials. The extent of the application of the cGMP system varies with the stage of the product. The quality system of the site has to guarantee compliance for all these type of products and need to be efficient as well, due to competitiveness in the market.
The cGMP system has to meet the needs of a project-oriented organization with many clients, products and product changes.
7. Knowledge and educational level
Academic level in a relevant discipline (Biotechnology, Biochemistry, Microbiology, Chemistry, Pharmacology, or equivalent).
8. Required level of experience
Minimum of 3 years’ experience in a (bio) pharmaceutical company, or demonstrated and transferrable skills from other related fields.
Knowledge of pharmaceutical cGMP quality systems and international cGMP regulations and guidelines.
9. Environment , Health & Safety
- Lead by example by demonstrating a visible and pro-active commitment to policies, procedures and the Life Saving Rules.
- Encourage individual responsibility and accountability for E, H & S.
- Implement and communicate the relevant E, H & S policies and procedures and enforce their use.
- Ensure persons in their area of control work safely and only perform tasks if currently competent and / or authorised.
- Ensure hazardous conditions, hazardous actions, incidents and near-miss incidents are reported.
- Participate in E, H & S activities (such as inspections, audits, incident investigations and risk assessments) as required.
- Not knowingly pollute the environment.
10. Patheon Behaviours
Customer (Internal and External) Focus
- Delivers added value to customers
- Pursues sustainable customer relationships
- Thinks outside-in
Drive for Results
- Drive to meet and exceed results
- Delivers with a sense of urgency and speed Makes it happen
Improve, Innovate and Change
- Achieves operational excellence
- Drives continuous improvements
- Stimulates ideas to emerge and develop Initiates and manages change
- Stimulates performance and development of employees.
- Builds open, supportive and diverse teams.
- Creates an inspiring and inclusive work environment.
- Leads by example.
- Acts in line with Patheon Values
- Takes personal ownership
- Contributes actively to joint results