Address
Form of work
Salary- Clinical Trials
- Coburg Area
- Patients First
Our client is a Melbourne-based a supply chain company with the core of its service "Direct-To-Patient model" allowing for IP to be delivered and administered in the patient's home. Their extensive experience working in collaboration with pharmaceutical companies, Contract Research Organisations, and medical research institutes, has enabled them to take the traditional and centralised clinical drugs trials process and, a clinical drug trials service set up to provide a revolutionary Direct-To-Patient delivery and Direct-From-Patient collection service.
The role
Reporting to the Quality Lead, the successful candidate will be responsible for supporting the maintenance and continuous Improvement of the Quality Management System - QMS. In addition, you will:
- Perform document control activities autonomously and provide monthly Quality metric reports and support data generation and analysis for management review.
- Review the implementation and efficiency of quality and inspection systems & standards.
- Review of Master Batch Records, Label Approvals and other documents related to production for execution of manufacturing operations.
- Review batches manufactured at CPL and approve and release for supply.
- Identify training needs and organize training interventions to meet quality standards.
- Investigate customer complaints and non-conformance issues.
- Reviews validation documentation, change controls, deviations and CAPA's.
- Conducts internal Audits regularly and coordinate and support on-site audits conducted by external providers, and evaluate audit findings and implement appropriate corrective actions.
- Equipment calibration and maintenance reports, Pest Control monthly reports and conduct Risk Assessments regularly.
- Approval and release of incoming goods & materials
- Assist in Supplier Qualification and performance monitoring.
- Maintain Archiving of Quality System records and regular prioritisation and selection of Quality initiatives.
The Expertise
- Sc., Bachelor of Pharmacy or equivalent professional experience
- Minimum of one year experience working in Quality Assurance in GMP environment.
- Familiarity with Quality Management System desirable.
- Product release experience
- Exposure to product, process, and equipment validation
- Experience in the use of Electronic Quality Systems
- Proficient in MS Word and Excel
- Skills: Attention to detail, Strong organizational skills
The application:
To join our client in this new and exciting opportunity, please email your cover letter & CV to Mark Thomas or Marilyn Jones at careers@mexec.com. Confidential enquiries to Mark or Marilyn on 1300 0 MEXEC
mexec delivers executive recruitment solutions to the pharmaceutical, biotechnology and broader technology industries. mexec comprises of highly talented and knowledgeable industry experienced Consultants that partner with leading organisations to grow their leadership teams.
We recruit at all levels including senior management, and we are currently recruiting for a variety of opportunities in the area of Sales & Marketing, Management, Medical, Regulatory Affairs, Clinical Research, Pharmacovigilance and Operations. Contact us today.
