Overview
Manage Quality Assurance Services within PHASTAR; Manage and maintain oversight of Company Policies, Standard Operating Procedures and Work Instructions, devise and implement the internal annual audit programme, generate and manage the CAPA process, conduct internal audits and host external audits/regulatory inspections. Deliver appropriate GCP training to staff and lead overall compliance with Clinical Trial Regulations and other applicable legislation.
Responsibilities
Responsibilities
- Develop and implement Quality Assurance strategies
- Generate and manage the internal audit programme
- Independently conduct and report audits in accordance with the internal audit programme
- Conduct Vendor Qualification Assessment Audits
- Lead, manage and coordinate external audits and regulatory inspections
- Maintaining tracking of audits conducted and report status
- Developing and Managing CAPA system including periodic reporting to management teams on company-wide issues / trends
- Manage the administration of procedural documents including the coordination, review and update; oversee the implementation of new procedures.
- Review and QA approval of all procedural documents
- Deliver appropriate GCP training to staff
- Develop measures of quality (Key Performance Indices) and monitoring systems for these measures; develop an implementation plan, roll-out and train staff on their use.
- Periodically report Quality metrics to PHASTAR Management
- Ensure PHASTAR staff have awareness and tools to allow company-wide compliance to clinical trial legislation and ICH GCP and other applicable legislation
- Provide advice and interpretation on new regulations and regulatory issues as they occur
- As part of the quality assurance function, ensure all staff are aware of the requirements needed to have complete and accurate training records; train staff on SOP compliance and maintenance of their training records
- Maintain personal training record
- Perform role in accordance with company policies and Standard Operating Procedures
- Ensure an overall awareness of the company processes
- Ensure high quality is fundamental to PHASTAR culture
Qualifications
Experience and Education Requirements
- Educated to Bachelor's degree level or equivalent
- Experience and training in regulatory affairs relating to clinical research and auditing
- Familiarity with clinical trial regulations and Good Clinical Practice (GCP)
- Computer literacy in Microsoft Windows, Microsoft Office (Word, Excel, PowerPoint)
- Knowledge of Quality Management Systems
