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Job Details

QA GCP Audit Manager

Company: Thornshaw Recruitment
Location: Dublin, Republic of Ireland
Reference: LD9525
Closing Date: 16 Dec 17
Type: Full Time
Salary (£): Negotiable
Benefits:

Job Summary:

Our client, a growing biopharmaceutical drug discovery and development company, are currently recruiting for a Senior QA Audit Manager. 

Requirements:

Our client, a growing biopharmaceutical drug discovery and development company, are currently recruiting for a Senior QA Audit Manager. 

The candidate must have a proven track record in Quality Assurance; leading GCP audits and overseeing compliance with all GCP, GLP and GMP requirements. The successful candidate will be involved in maintaining, developing and continually improving the organisation’s Quality Management System and ensuring a Quality culture is present throughout the organisation. 

Responsibilities: 

  • Lead and contribute to the improvement and maintenance of the company QMS. 
  • 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. 
  • Support other aspects of the business as needed. 
  • As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement. Travel (approximately 10-20% depending on operational activities) domestic and/or international. 

Experience, Skills, Knowledge Requirements: 

  • Bachelor’s Degree (minimum) in medicine or general science. 
  • Proficient in QA procedures and a thorough knowledge of relevant GxP standards.
  • Proven experience (min. 5 years) in Clinical Quality Assurance auditing. 
  • Ability to review and evaluate clinical data / records. 
  • Experience of leading CAPA initiatives 
  • Ability to successfully implement quality plans for all types of systems/processes. 
  • Ability to liaise successfully with departmental and office management. 
  • Demonstrated coaching/mentoring skills. 
  • Good problem resolution skills. 
  • 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. 
  • Strong QMS experience 

For more information and to apply for this role please call Linda on +353 1 2784671 or e-mail ldunne@thornshaw.com 
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Www.thornshaw.com Tel: +353 1 2784671

Apply for this job: QA GCP Audit Manager

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

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