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SRG are currently working with a global leader within Biopharmaceuticals. Their innovative products and market leadership positions are driven by people with a passion for making a difference.
Title: Lead Auditor
Location: North West of England
Really attractive salary
Benefits: 15% bonus, Life Insurance, Healthcare, attractive pension and more
50% travel required for this role (foreign and domestic)
This role supports the Product Development Quality Assurance Audit Program and involves performing cGMP audits and assessments of service providers related to research and development project supply chains. It will involve auditing internal, acquired, and external manufacturing, packaging/ labeling, laboratory, suppliers of GMP relevant materials, components, storage & distribution, services and activities supporting clinical manufacture and packaging for human use.
- Participating in the risk-based planning and scheduling of audits
- Engaging the appropriate business partners in all stages of the audit process
- Ensuring assigned audits are completed and reported in a timely manner
- Supporting continuous improvement efforts, e.g. supplier management, audit tracking modules, development of processes, procedures, tools and training materials.
- Extensive pharmaceutical, medical device or biologics experience in drug development, manufacturing, laboratory, quality assurance, or GMP/ISO/Quality auditing.
- Experienced in auditing principles and techniques, inspection requirements, and performing cGMP audits of pharmaceutical suppliers throughout a drug development program
- Knowledge of EU GMPs, Device or Biologic regulations and ICH guidance's and International Standards (Risk Management, ICH 8, 9, 10)
- Knowledge of other International GMP, Device or Biologic regulations (ANVISA, Japan, Canada etc.)
- ASQ Certification or similar certification as a Quality Auditor, Manager or Engineer a plus
SRG are the UK number 1 recruitment company specialising in the science, engineering, clinical, pharmaceutical, food/FMCG, renewable, biotech, chemicals and medical devices sectors. As scientists ourselves, our specialist sector knowledge and our passion are second to none. It's this combination that makes us different. We're committed to providing outstanding temporary, contract and permanent career opportunities of all levels for our candidates and a comprehensive range of expert strategic recruitment services for our clients.
If you would like to apply for this position, please use the link provided. Alternatively please email a copy of your CV to Behruz Sheikh at firstname.lastname@example.org. For more information regarding this position or any others, please call Behruz on 0161 868 2202.
If you have a scientific background and this position is not relevant / suitable for you please feel free to get in touch or visit www.srg.co.uk to view our other vacancies.
Keywords: GMP/ISO/Quality auditing, supplier auditing, lead auditor, CMO Audit, ICH 8, 9, 10, GMP relevant materials audit, components audit