Title / Position:Senior Consultant and Managing DirectorE-mail Address:NigelCryer@BlucielaLifesciences.comTelephone: +33786215433Website URL: N/ASocial Media Profiles: https://www.linkedin.com/in/nigelcryer/Location: FranceLanguages spoken: English (native), French A2, German Q2Geographic Areas Covered: GlobalName of Firm: Bluciela-Lifesciences SASNo. of Practising Consultants: 10
Educational / Professional Background:Academic Qualifications (degrees, diplomas, etc.) BSc (Hons) Applied ChemistryCertifications and Accreditations relating to Pharmaceutical Good Distribution Practice (GDP)Approved Lead Auditor (Sanofi, J&J, AZ, Merck&Co Norgine, NextPharma)Membership of relevant professional organizations or associationsISPEInvolvement in GDP-UCIChairman of Training Group; Member Guidance & Solutions PWG, Member of Advisory Board and Governing Council
Professional Skills, Experience and ExpertiseNo of years of experience in Pharmaceutical Good Distribution Practice (GDP)25 Previous Companies worked for in the Pharmaceutical Industry:AstraZeneca, Merck&Co, DHL Lifesciences, Roche, Norgine, Watson, J&J, NextPharma, Sanofi, (Top 50 pharmacompanies: as DHL Lifescience VP Business development & Quality)Specific areas of specialism or particular experienceDeep hands on knowledge of all areas of Biotech & Pharmaceutical Quality including all areas of logistics - Air, Ocean, Road, Courier, Mail, Rail, Computerised systems, Data Integrity, Quality systems, Auditing, Training, Organisational analysis, Temperature mapping and monitoringFamiliarity with Specific Regulatory Frameworks and GuidelinesEU cGMP, GDP, FDA cGMP, Health Canada, TGA,Relevant Training or Courses AttendedMany courses provided as an SME and attended over the last 40 yearsSoftware or Technical Skills related to Pharmaceutical Supply Chain ManagementImplementation of SAP, Validation of ERP, Change control, Logistic management systems (Control Towers)
Client Testimonials / References:Professional referencesAvailable on request References or links to case studies / past projectsShake Test: https://iris.who.int/bitstream/handle/10665/270736/PMC2908964.pdf?sequence=1
Other InformationBuilt strategies for DHL Lifesciences and many of its customers (Most work confidential) - Global distribution projects, Logistic management systems (Control Towers), SAP/ERP, Delivery of 2.5m Malaria nets in Kenya.1st FDA standard validation of passive packaging, Validation of the Shake test (to detect frozen vaccines), Design & implementation of Regional Hub distribution
In their own words:
“My approach is to focus on the critical aspects while ensuring guidance on operational excellence and knowledge sharing”
Good Distribution Practice - Universal Compliance Initiative