Desired Profile:-Proof of registration as a -Registered Nurse with the SANC.
-Post basic qualification in Operating Theatre technique.
-At least 5 years experience in Operating theatre.
-Experience in scrubbing fo
Required Experience:1-5 yrs
Salary: R25 000 p/m CTC
Vacancy Details
Posting Details:
Job Category:
Clinical Research
Job Title:
Quality Assurance Manager
Healthcare Facility or Agency Name:
International Clinical Research Organisation
Agency Profile:
CRO
Reqired Experience or Credential:
Experience:
A minimum of 4 years experience in Clinical Monitoring incl2 yrs exp to experience in a role equivalent to CTL. And 3 years QA experience yrs
Required Education:
Degree in life sciences or equivalent nursing qualification. Fluent in English. Computer literate.
Posting City:
Province:
Gauteng
Salary:
Market Related
Benifits of Job
Job Description:
The Quality Manager will be responsible for conducting a Quality Control program, in their region/ country, to assure our customers and XXXXX Management that Clinical Operations are compliant with relevant regulations and guidelines, including ICH GCP and the EU Clinical Trails Directive in addition to local country regulations and XXXXXX policies and procedures. This person will provide advice and support to Clinical Operations in their region/country, including CRAs, CRMs and local /regional trainers, on all aspects of compliance, SOP development and customer requirements and will work closely with operational teams to review audit reports, prepare corrective action plans and follow these through to completion.
The person will also recommend and implement quality improvement initiatives in their region/ country.
RESPONSIBILITIES (Accountabilities, including financial/ staff/ material data as appropriate, and Primary Tasks)
1. To create, implement and maintain a Quality Plan for the region/country, which complements initiatives driven centrally by either Quality Services or Clinical Operations. This will include:
• planning and executing the Quality Control activities within the region/country
• producing quality control checklists
• producing relevant policies e.g. field base policy
• creating activity reports for management
• planning and conducting investigator site visits to review CRA monitoring practices and provide guidance for improvement
• assisting with office inspections
2. To create and maintain both a Quality and an Audit Manual for the region/country.
3. To initiate and/or facilitate quality improvement initiatives by establishing and Chairing Quality Groups at each office. The purpose of the Quality Groups is to review audits, corrective action plans, quality issues, assisted site visits, feedback on interaction with QS, training issues, etc. to develop and track the impact of improvement initiatives.
4. To work with the local/regional trainers to provide training for Clinical Operations employees, as required, including:
• ICH and GCP
• SOPs
• audits and inspections
• regulatory updates
5. To act as the conduit between the local offices within the region/country and Quality Services, attending periodic meetings/teleconferences to exchange performance related data and information on quality issues and initiatives.
6. To oversee preparations for customer audits and assist in the development and completion of suitable corrective action plans.
7. To work with the document owners to ensure that local work instructions and guidelines for Clinical Operations staff are maintained up-to-date..
8. To inform Quality Services, the Regional DCR and the Regional Head immediately upon receipt of any information concerning possible regulatory inspections or suspicions of fraud or misconduct, in accordance with appropriate operating procedures/ work instructions.
9. To inform Quality Services of significant quality issues as they arise, in accordance with appropriate operating procedures/ work instructions
10. To assist Quality Services in the management of quality issues and regulatory inspections in the region/country.
11. To prepare periodic reports on quality related matters in the region/country and progress with quality initiatives for the DCR/Head of region/country.
12. To work with Clinical Operations staff in the region/country to follow up on corrective action plans and to ensure that actions are completed and adequately documented within an appropriate time frame.
13. To have a customer facing role for the region/country for quality related issues.
14. To perform any other reasonable tasks as required by the role.
