Job Description
An innovative biopharmaceutical organisation, focused on discovering and developing new therapeutics, now seek to expand their team with the appointment of a QA Audit Manager.
The successful candidate will be involved in maintaining, developing and continually improving the company Quality Management System (QMS) and ensuring a Quality culture is present throughout the organisation.
The ideal candidate will have a track record in Quality Assurance; leading GCP audits and overseeing compliance with all GCP, GLP and GMP requirements.
Travel (approximately 10-20% depending on operational activities) domestic and/or international.
Responsibilities of QA Audit Manager, GxP:
Lead and contribute to the improvement and maintenance of the QMS, in line with company culture of process improvement.
Plan and conduct routine and risk-based QA audits and inspections of the company quality system, and clinical trial sites, on an international basis in order to provide assurance of compliance with the company QMS, relevant standards, regulations and guidelines.
Ensure that audit results and other quality information are formally and consistently recorded and reported and that corrective actions/preventive actions are documented effectively.
Oversee the documentation and tracking of QMS activities, including deviations and change controls, and the implementation of corrective actions.
Verify that the quality system is being implemented both internally within company and externally with outsourced company vendors.
Maintain and develop the vendor oversight process, and perform vendor audits and assessments.
Perform staff training regarding the company Quality system, applicable standards, and regulations and on external audits/inspections.
Requirements for QA Audit Manager, GxP:
Honours Bachelor's Degree in medicine or general science. Advanced qualification preferred.
Proficient in QA procedures and a thorough knowledge of relevant GxP standards.
5+ year's proven experience in Clinical Quality Assurance auditing.
Ability to review and evaluate clinical data / records.
Strong QMS experience and proven experience of leading CAPA initiatives.
Ability to successfully implement quality plans for all types of systems/processes.
Good planning and organizational skills with the ability to multi-task and prioritize effectively.
Competent computer skills including experience with EDMS and computerized audit management systems.
Demonstrated coaching/mentoring skills.
Attractive salary and benefits offered, depending on experience.
Please contact Larry on +353 1-2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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Key Words: FDA, GLP, ICH, GCP, Clinical Research, Clinical Trails, QMS, GCP Auditor, QA Auditor, Pharmaceutical, Biopharmaceutical, Medical Devices, Dublin, Ireland.