Our client is a new player in the pharmaceutical industry. Their organisation focuses on GMP manufacturing, along with clinical trial project management services. Due to strong growth, they are currently in the market for a Quality Director to help support the requirements of their operational needs.
We are seeking applications from candidates interested in either a part-time or full-time position. The role will be responsible for overseeing the activities of a small manufacturing facility and warehouse - Ensuring that activities are compliant to the QMS, maintenance and calibration schedules, and environmental monitoring.
A strong focus on handling third party auditors will also be involved in this role.
Duties will include (but are not limited to):
- Prepare Site Master File, Operational Qualification and Installation Qualification Documents
- Execute IQ/OQs as required for facility, equipment, etc
- Coordinate, draft, approve SOPS, Forms, Registers and Templates as required and maintain control copies of these documents as required.
- Maintain staff training files and assist in staff training as required
- Conduct internal audits in line with the agreed annual audit program. Report findings and follow up closeout of findings.
- Maintain equipment and facility calibration and maintenance as required
- Develop an external audit program and conduct external audits in accordance with the program on critical service and material suppliers
- Review and release incoming materials and finished compounded products
- Oversee pharmacy returns and destruction in conjunction with the relevant operational staff
- Review and approve production records and associated documents
- Maintain registers for Production Batch Numbers and executed production records and ensure appropriate storage
- Establish and maintain an appropriate pest control program
- Establish and maintain environmental monitoring plans for the compounding facility
- Participate in client audits, review audit reports and finalise closeout
- Participate in risk assessments for new incoming projects
- Investigate complaints and deviations as required and manage the Pharmacy's CAPA management plan
- Undertake annual mock recall and coordinate recall activities if and when required
- Chair the Quality Steering Risk Team (QSRT) meeting and provide agenda and minutes on the meeting
To be considered for this role:
- Bachelor degree in Science, Pharmacy or equivalent
- Strong management experience in a QA role
- Strong experience within a compounding pharma manufacturing environment
- Strong written and verbal communication
- A strong team player with a collaborative approach
- Strong salary remuneration
- Being part of a fast-developing start-up pharmacy
- Great team environment with flexible working options.
If you this sounds like you, then please hit the apply button now!
Please apply with your covering letter and resume in Word format.
Questions can be directed to Leah Creswick at Fuse Recruitment on 0478 193 170.