Senior Quality Assurance Auditor

RESPONSABILITATI

We are currently recruiting for a Senior QA Auditor to join our team. The main responsibilities will be as follows:

•Conduct GXP audits (GXP= GCP/GLP/GMP), and/or consultancy projects for customers, as applicable, according to company’s departmental and/or customer policies and procedures, within budget and agreed timelines. • Schedule, prepare for, conduct, report, and close out all audits assigned, under the supervision of QA management. This may include, but is not limited to, audits of clinical study documents (protocols amendments, informed consent, clinical study reports, advertisements) Project Set-up, Project In-Life, Investigator Sites, Databases, Study Reports, and Sub-contractor audits
•Plan, conduct and report audits of clinical research activities in any of the countries involved in the company’s contracts to assess compliance with customer requirements, company’s Core Operating Procedures, Work Instructions and project specific guidelines/instructions.
•Ensure that the QA audit scheduling database is updated.
•Act as deputy for Manager, where appropriate, in planning and scheduling audits, in managing quality issues, in summarizing QA activities, etc.
•Review Corrective Action Plans, as required.
•Develop audit plans in conjunction with the relevant Manager, QA.
•Report quality/compliance issues, to line management and to relevant Manager, QA.
•Advise / communicate to QA management the perceived need for audits of Quintiles systems.
•Develop a further working knowledge of current GXP regulations, guidelines, company procedures and related auditing techniques.
•Assist in the conduct of customer audits, mock regulatory inspections and regulatory facility inspections as and when required. May host customer audits and work with responsible parties to prepare corrective action plan as applicable.
•Acquire special areas of GCP and QA interest, as agreed with QA Management and act as a QA liaison to other quality assurance groups to develop these (e.g.; GMP/Phase I Units).
•Act as Mentors to Auditors when assigned to do so by the Director, QA.
•Assist in offering GCP and audit training to other departments and to customers as and when required .
•Assist in developing QA procedures, practices and systems.
•Use company’s systems and practices for recording use of time particularly in conducting contracted QA activities.
•Extensive travel.

CERINTE

DESCRIEREA FIRMEI

Hays Pharma is a leading global pharmaceutical and biotech staffing business that provides mid to upper level staff involved in drug discovery, clinical development, post-approval services and commercial activities.