Technically experienced Pharmaceutical, Biotech and Medical Device Compliance professional combining Technical and Validation expertise with strong people skills. Pragmatic approach to problem solving and application of theoretical knowledge across a range of organisational environments. Specific areas of expertise Include:
Computer Systems validation (CSV) Automation Validation Equipment and Process validation Change Control Compliance auditing Process definition cGMP Integrated Qualification and Commissioning	SW Product Management Systems Implementation and Integration Validation and Compliance Training 21 CFR Part 11 Assessment & Remediation GAMP, ISPE, ICH FDA and EU Regulations Quality Systems Implementation Risk Based Validation