An amazing opportunity has arisen for a Site Lead Auditor. This role will be responsible for leading the implementation of the Site Internal Audit Program and supporting the launch of the Inspection Readiness Program ensuring the processes comply with GMPs, Health Agency regulations and all other applicable governing regulations.
Bring energy, knowledge, innovation and influence to carry out the following:
* Comply with company and regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
* Ensure there is an effective Quality Management System in place.
* Lead proactive evaluation of site compliance against emerging regulatory trends.
* Support deviation and atypical close out and initiate/follow up on Corrective and Preventive Actions
* Initiate and maintain Quality related metrics related to the Site Internal Audit program, ensuring effective communication and follow up
* Represent the sites Quality Management System during Board of Health inspections
* Manage the internal audit schedule
* Effectively communicate audit/inspection results to stakeholders. Evaluate root cause analysis, Corrective and Preventive Actions (including responses, completion, and effectiveness) for audits & inspections.
* Lead the preparation and host Health Authority inspections and Divisional Audits.
QUALIFICATIONS AND EXPERIENCE
* BSc/BEng Chemistry/Biology/Microbiology/ Automation/Engineering or a relevant discipline
* Seasoned Site Inspection & Audit professional with a circa 12 years' working knowledge in the Pharmaceutical or Biological industry.
* Minimum of 4 years' direct involvement in delivering Site Internal Audit programs and Inspection Readiness programs in a regulated environment
* In-depth knowledge of US and European cGMP guidelines and ICH guidelines
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
Fastnet - The Talent Group
'Not Just Placers.........Partners'
The Life Science Specialists