Dr Maureen Dennehy

SERVICES

  • ISO 13485 QMS, GMP and Lean operations
  • Auditing, monitoring and Management Review
  • ISO 14971 Risk Assessment facilitation
  • Mentoring, virtual training and events
  • Specialities in sterilization, GAMP, qualification and validation. 

PARTNERSHIPS

  • Solutions: low-cost cloud QMS, GS1 barcoding, temperature loggers.
  • Contract-In: independent/part-time contractor pool for agile support to manufacturers for specialist work or peak periods. 
  • CCi-Growthcon: shop-floor implementation of Lean (5S, waste reduction, visual management, problem-solving) and continuous improvement. Strong supply chain and scheduling capabilities. 

CREDENTIALS

  • >20 years in biological, pharmaceutical, medical device manufacturing. Set up QA, QC & Validation departments at Biovac (head of Quality).
  • Expert knowledge of standards and guidances: e.g. SAHPRA, PIC/S, ICH, EU, WHO, FDA, TGA, ISPE, many ISOs and GXPs, GAMP, pharmacopoeias, biosafety/biosecurity.  
  • ISO 13485 Lead Auditor (BSI) & IRCA Pharmaceutical Quality Systems Auditor (NSF)
  • ISPE Certified Pharmaceutical Industry Professional (CPIP).
  • MBA, PhD, Datametrics. 

CONTACTS

  • Cell: +27-82-3076875
  • Email: maureen@qast.co.za
  • Based in: Cape Town
  • Web page: www.qast.co.za Quality Assist.
  • Linked In: https://www.linkedin.com/in/maureendennehy/