The Reference Standard coordinator is responsible for the continuous coordination of all relevant aspects referring to the Reference Standards within Patheon Biologics Australia Pty Ltd. (“Patheon”).
Key Areas of Accountability / Responsibility
Maintaining the reference standard system on a daily basis, including communications with relevant parties/departments, facilitating the ongoing use of reference standards and forecasting/tracking the status of all reference standards. Liaise with the Project Management team and the Quality Assurance departments about timelines for laying down and release of a standard. Partake in Customer calls to discuss status of reference standards Subject Matter Expert for reference standards during Customer/Regulatory audits /visits. Undertake long term and short term planning for the reference standards Laying down the Reference Standards: -
- Review of the Reference Standard Questionnaire
- Preparation of all the relevant documentation: Analytical Protocol, Logbooks,
Reference standard protocol, Reference standard specification sheet
- Aseptically Filling vials
- Pull samples for the qualification of the reference standard
- Organize qualification testing with the different QC teams
- Manage the release activities to support On time Delivery Retest program of Reference Standards:-
- Pull samples for re-testing
- Organize qualification testing within the different QC team
- Organize qualification testing within the different QC team Organization of and issuing reference standards for use in analysis. Keeping Reference standard procedures and associated documentation up to date
Improving the Reference Standard system, and maintaining the system according current guidelines and industry standards.
Knowledge and educational level
- Degree in Science (BioTechnology / Chemistry, or similar)
- Specific knowledge of Bio-pharmaceutical processes, Pharmaceutical guidelines and principals of Good Manufacturing Practice, preferred
- Proficient with Microsoft Word, Excel and Power Point.
- Familiarity with principles of Aseptic techniques, preferred.
- Good knowledge of English and English Grammar
Required level of experience
- Minimum of 2 years’ experience in the Bio-pharmaceutical or Pharmaceutical industry.
- Proven record of ability to work as a team member and independently.
- Experience in multitasking, prioritizing and showing initiative to complete tasks according to company milestones.
(Ability to adapt to day to day business requirements)
(Demonstrates ability to work with all departments and colleagues of varied backgrounds)
- Continuous Improvement
(Demonstrates the ability to challenge the status quo to improve outcomes)
- Customer Focus
(Demonstrates the ability to deliver on promises made to customers. i.e. meet agreed due dates)
- Initiating Action
(Demonstrates the ability to work independently, and manage planned work)
(Ability to work on multiple projects or tasks simultaneously)
- Managing Relations
(Demonstrates the ability to manage customer demands with respective business requirements and agreed timelines)
- Quality Orientation
(Ability to interpret and apply GMP principles, strong attention to detail and accurate
data input and transcription, strives for right first time in every task undertaken)