Production Support Coordinator - Parkville, Australia - Seqirus
Description
The Opportunity
Seqirus is looking for a
Production Support Coordinator to join the Production Support team at our Parkville site.
Reporting to the
Production Support Team Leader, you will be contributing your experience and knowledge and providing support to manufacturing staff and processes within each functional area to produce the required product in accordance with current Good Manufacturing Practice (cGMP) and the Seqirus Quality Management System.
This role will be either a fixed term position ending 30 June 2024 or a Secondment position, depending on your current employment status at CSL.
The Role
You will be responsible for the delivery of a variety of outcomes through the effective management of processes and systems
This will include:
- Support a team to ensure that the product is manufactured in accordance with cGMP and the Seqirus Quality Management System
- Assist internal and external audit preparation and responses and provide updates on progress and timelines
- As directed, assist manufacturing areas with deviation investigations
- Proactively support the operational area to prevent, investigate and document deviations and out of specifications, including EHS incidents and compliance with DAWE and OGTR regulations
- Actively seek, recommend and implement improvements within each functional area
- Facilitate the training and development of staff in accordance with the Quality Management System to ensure enough competent employees to undertake all processes
- Understand and communicate dossier requirements (where relevant to the role), and ensure consistency throughout SOPs and BPDs.
- Build collaborative relationships with key Quality Assurance, Quality Control, Validation, Engineering and Maintenance staff
- Support a safe work environment in compliance with CSL policies and procedures and statutory obligations through effective EHS practices and systems
Your Skills and Experience
- Degree in a Scientific discipline highly regarded, or extensive similar onthejob experience.
- Strong technical understanding of pharmaceutical manufacturing processes.
- Knowledge of cGMP/FDA/TGA/OGTR/DAFF regulations.
- Experience with deviations and change controls and writing document updates and procedures.
- Strong verbal and written communication skills.
- Experience working physically with cGMP processes including aseptic and gowning environments.
- Strong customer focus, problem solving skills and ability to work collaboratively with internal customers.
- Selfmotivated with the ability to work with mínimal supervision.
How to Apply
LI-Onsite
Our Benefits:
CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives.
About CSL Seqirus:
CSL Seqirus is part of CSL Limited (
ASX:
CSL).
As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness.
In Australia, CSL Seqirus is also a leading provider of speciality pharmaceuticals and other essential vaccines. Learn more about CSL Seqirus.We want CSL Seqirus to reflect the world around us:
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL Seqirus.
Do work that matters at CSL Seqirus:
**Watch our 'On the Front Line' video to learn more about CSL Seqirus
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