Quality Assurance QMS Document Controller
Maintenance of the company Quality Management System's documentation, in accordance with company procedures and TGA & PIC/s guidance
Summary about this job
Quality Assurance & Control
Company: Phebra Pty Ltd
Location: Sydney
Work type: Full Time
Salary: n\a
Phone: +61-3-7392-1019
Fax: +61-8-7254-8320
E-mail: n\a
Site: n\a
Detail information about job Quality Assurance QMS Document Controller. Terms and conditions vacancy
- Phebra is a privately owned Australian manufacturer of specialised medicines
- A great opportunity to work in a state of the art sterile manufacturing facility
- A chance to develop your career in Quality Assurance
QA QMS Document Controller
Phebra, is a privately owned Australian manufacturer of specialised medicines for the local Australian, New Zealand and wider export markets.
An opportunity exists to join our Quality Assurance team in our state of the art, sterile injectable manufacturing facility at Lane Cove West.
Reporting to the Quality Assurance Supervisor the role forms part of the quality assurance team ensuring Phebra’s compliance with cGMP and PIC/S.
Key day-to-day tasks of this role include;
- Log each action in the change control system;
- Add draft templates, where required, to the server after other staff members have completed change control request forms;
- Format documents to the required specification and then circulate for review;
- Ensure Batch Manufacturing Records are made available for use in production as appropriate;
- Maintain training database for all company staff;
- Provide management with regular department training percentages;
- Assist in the review of all documentation within the QMS and WHS system, ensuring all documents are kept up to date and comply with the requirements of cGMP and WHS legislation as required;
- Generation of the Quarterly Schedule 5A report for submission to the TGA;
- Writing and review of relevant Standard Operating Procedures;
- Maintain appropriate documents and files as they relate to the areas of responsibility.
- Maintain the deviation log and track the progress of deviations.
- Create security-controlled pdf copies of all QMS documents.
- Upload security-controlled pdf QMS documents to the Phebra Intranet
The following experience and skills would be highly regarded;
- Previous experience in working in a GMP environment
- Advanced knowledge of Microsoft Office, specifically Word and Excel
- High attention to detail with excellent organisational skills
Phebra is and equal opportunity employer.
Our values are the foundation of our business; Quality, Accountability, Teamwork and Leadership.