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We are currently looking for a Senior Auditor to join a global pharmaceutical company based in the London area. As the Auditor you will be responsible for conducting internal and external GMP audits. This will include Suppliers and Vendors to ensure compliance against regulations and Quality Agreements.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Senior Auditor will be varied however the key duties and responsibilities are as follows:
1. You will conduct on-site GMP audits of suppliers and will identify and evaluate risks. You will work alongside suppliers, developing and distributing formal findings and reports. You will also be tasked with generating and developing the audit schedule.
2. You will conduct internal audits throughout the EMEA region, identifying, evaluating and acting upon potential compliance issues. Findings will be documented and reported back to senior management.
3. As the Senior Auditor, you will assure internal and vendor compliance with corporate policies, SOPs and regulatory agency standards. Any non-compliance issues identified will be mitigated with corrective actions. Findings and formal CAPA plans will be reported back and agreed upon with Senior Management.
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.
To be successful in your application to this exciting opportunity as the Senior Auditor we are looking to identify the following on your profile and past history:
1. You will have previously conducted external audits. Experience auditing manufacturing sites of pharmaceutical or biological products is essential, whilst warehousing and packaging site experience would be beneficial.
2. Proven experience working within a Pharmaceutical company, working to strict regulatory guidelines, such as GMP and GDP standards. Knowledge of technical regulations such as GAMP 5 would be advantageous.
3. People management experience is not essential for this position, however desirable. This is the same for Qualified Person status.
Key Words: Quality Assurance | QA | Quality Manager | Audit | Audit Plan | Senior | GMP | GDP | Manufacturing | Pharma | EMA | MHRA | FDA | Audit Plan | CAPA | QMS | Travel
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.