International GMP Pharma Auditor - Global CMO
My client, an international healthcare company is looking for a international GMP auditor and compliance manager to lead their international quality audits inline with GMP guidelines.
Your primary focus will be to carry out internal and external GMP audits of CMO, suppliers and service providers.
- To prepare the annual audit plan - internal and external.
- To carry GMP/GDP audits of suppliers and CMOs
- To carry out Internal Audits including Self Inspections of Affiliate companies
- To host GMP/GDP audits
- To follow up post audit CAPA's and actions
- To review and approve stability, validation, technical transfer and technical protocols
- To carry out GMP/GDP training
In order to be considered for this position you should have:
- Experience of Quality systems to include but not limited to Change Controls, Complaints,
- PQRs,KPI management and Audits is a must
- GMP/GDP experienced Audits of CMOS
- Internal audits including self inspections of affiliate companies
- Follow up on post audit CAPA and action
- A Life Science degree or equivalent
- Pharmaceutical Quality System Auditor Qualification (preferable) e.g. IRCA Lead Auditor
- Excellent working knowledge of international GMP/GDP especially in the interpretation of MHRA and FDA requirements, for the manufacture, control, and distribution of commercial product
- Sound knowledge of the principles of sterile and non-sterile solid processes, including for solid and semi-solid, liquid dosage forms
- Sound knowledge of QC and Stability chemical analytical testing techniques
- Familiar with regulatory requirements for validation activities as applied to manufacturing and packaging processes, analytical methods, cleaning procedures, and computerised systems
- Familiar with the appropriate EU Directives, EU and USA regulatory processes, ICH Guidelines
This position is based around Edinburgh.
KEY WORDS: QMS, Quality Management System, Quality Assurance, Risk Management, Compliance, CAPA, Medical Devices, German, ISO 13485, ISO 9001, GMP, Medical Device jobs, Ireland, Nonstop recruitment, Manufacturing, Engineering, process optimization
If this role is of interest to you then do not hesitate to get in contact today as my client is looking to select suitable CV's in the next week. Please send your CV in MS Word format (I am unable to accept PDF copies!) to me directly, Ruby Wallace, at , or by calling me on for a discussion in confidence.
NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.