Annick NICLAS has more than 25 years’ experience in GMP and Quality Management System helping pharmaceutical and medical device organizations to comply with GMP/QS-expectations. Annick’s objectives are to enhance workforce knowledge and motivation and to promote a correct attitude towards quality. Her skillset is on quality management and change management providing industries with technical consultation, coaching and training.
As Quality Vice President and Qualified Person, Annick has proven her expertise within pharmaceutical and medical device operation areas. A mix of customer focus, quality spirit, innovation and enthusiasm, she has work as leader within quality system improvement, new cultures and performance management implementation.
Annick could bring her expertise and be involved in the following areas:
- Quality Management System implementation and maintenance:
- EU and US GMP – GDP – ICH Q8, Q9, Q10 – 21 CFR 480 – ISO 9001 – NF EN ISO 13485
- GMP systems and processes: internal audits & audits of sub-contractors, deviations & investigational tools, CAPA, change control, customer complaints, quality agreements and documentation.
- Quality process improvement and simplification. Quality Governance.
- SWOT analysis, Strategic Objectives, Quality Policy and KPIs.
- Performance Management and Change Management.
- Skills assessments, Coaching, Quality training programs.