Job Reference: J5632857
Updated On: 14/04/2020
Status: Now Interviewing
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Role OverviewWe are currently recruiting for a Lead Auditor to join a global pharmaceutical company based in the South East region. As the Lead Auditor you will be responsible for Customer and Regulatory Audit programmes and the Investigation management processes.
Key Duties and ResponsibilitiesYour duties as the Lead Auditor will be varied however the key duties and responsibilities are as follows:
1. You will have oversight and will conduct on-site GMP audits of suppliers and will identify and evaluate risks. You will also be tasked with generating and developing the audit schedule and implementing a standard Audit and Investigation process.
2. You will implement a standard Audit programme that will be used by the Audit team. This will be to ensure that customers receive the same standard of audits from cradle to grave. This includes the back office audit prep, the findings and investigations.
3. As the Audit Manager, you will work cross functionally to ensure that root-cause analysis is completed appropriately and that appropriate CAPA's are implemented, with the final reports being submitted efficiently.
4. You will conduct and coordinate compliance and Quality training as required. This will include generating Key Performance Indicators and audit related metrics in support of staff development.
Role RequirementsTo be successful in your application to this exciting opportunity as the Lead Auditor we are looking to identify the following on your profile and past history:
1. You will have previously conducted internal and external audits. Experience auditing manufacturing sites of pharmaceutical or biological products is essential.
2. Proven experience working within a Pharmaceutical company, working to strict regulatory guidelines, such as GMP and GDP standards. You must have had experience hosting Regulatory Agencies, such as the MHRA or FDA.
3. People management experience is not essential for this position, however desirable.
Key Words: Quality Assurance | QA | Quality Manager | Audit | Audit Plan | Senior | GMP | GDP | Manufacturing | Pharma | EMA | MHRA | FDA | Audit Plan | CAPA | QMS | Travel
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