This opportunity is suited to a tenured Quality Systems Specialist as you will be supporting on the implementation and management of a new QMS for site.
In this role you will work closely and report operationally into the Qualified Person / Vendor Manager in terms of technical support, escalation point and governance oversight for a busy GDP environment.
This role is supporting on a key site project so will initially be 12 months in duration.
KEY RESPONSIBILITIES:
- Development, Implementation and Maintenance of the QMS
- Ensuring All operating procedures relating to QMS, are followed, reviewed and that required training is given to relevant staff.
- Responsible for safeguarding product users against potential hazards arising from poor distribution practices
- Generate procedures to oversee all distribution activities that affect the identity, traceability and quality of a wide range of medicinal product.
- Ensuring that initial and continuous training programmes are implemented and maintained.
- Coordinating and promptly performing any recall operations.
- Ensuring that relevant customer complaints are dealt with effectively.
- Ensuring that suppliers and customers are approved.
- Approving any subcontracted activities which may impact on GDP.
- Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary CAPAs are put in place.
- Deciding on the final disposition of returned, rejected, recalled or falsified products.
- Documenting deviations and deciding on CAPAs to correct deviations and avoid their reoccurrence and monitoring the effectiveness of those CAPA's
- Temperature monitoring to be in place in all required warehouses and associated documentation to be maintained.
- Under the responsibility of the Control Drugs Officer, this role is responsible for the management of all operating procedures in relation to controlled drugs.
QUALIFICATIONS & COMPETENCIES:
- Bachelors/master's in quality or Pharmaceutical Science discipline
- A strong knowledge of European GDP Guidelines and relevant legislation
- Demonstrate an ability to implement a Quality Management System and all relevant SOP's.
- Minimum 3-5 years' experience working within Quality Assurance
- Prior exposure to GDP, with a focus on compliance and continual improvement is highly advantageous.
- Excellent written and communication skills
If you would like to find out more about this role please click the 'Apply Now' button below or reach out to Kellie on 021 2300 300.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
