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/