Kelly S.
Senior Technical Consultant @CAI
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WORK HISTORY
Senior Technical Consultant @CAI
GB
EDUCATION
University of Sunderland
Chemical and Pharmaceutical Science
ABOUT KELLY S.
I am a highly motivated Quality Manager / Project Manager / Analytical Manager / Lead Auditor /Validation Lead. My experience is in many areas of the chemical and pharmaceutical / biopharmaceutical sector including, analysis and validation / method development and transfers. New facility build / facility expansion / improvements, installation and commissioning / qualification / validation of laboratory / manufacturing instrumentation / equipment, as well as computerised systems validation (CSV), auditing, and stability and transport of API’s and biopharmaceuticals. I am flexible and can adapt quickly to meet business demands. I am comfortable working remotely and travelling for work and I am quick to learn new methods, procedures, and ways of working, keeping integrity at the forefront at all times. KEY SKILLS Project management Advanced laboratory practice IT Competency / Statistics Exceptional Interpersonal skills Exceptional Organisational skills High level CMC / GMP / GLP / GDP /GCP Quality Management Systems (QMS) Global cGMP Regulations / ICH Guidelines (including EU / FDA / TGA / MHRA) Regulatory Submissions (EU and FDA) Auditing / Gap Analysis (Regulatory, Client, site) Vendor Assurance / Quality and Technical Agreements Batch Disposition / Product Approval Manufacturing Aseptic Technique / Manufacturing Effective troubleshooting Method Development Method Validation / Transfers Instrument Installation / Qualification / Validation SOP / Policy / Document generation Media Fill Non-conformance / deviation / OOS investigations (Laboratory and Manufacturing) Continuous Improvement (5S)/ Root Cause Analysis, KPI’s, DOE, RACI, LSS Stability Study Creation and Management People Management and Training Electronic System Administration and computer system validation / assurance (CSV / CSA)/ Digital Quality Data Integrity Reference Std Management, Characterisation and continued suitability of use (CSU) ISO 17025, 13485, 9001, 45001, 14155, 20916, 15189, 10993 ISPE / PDA / ICH / CFR CQV (facility / manufacturing / laboratory) OR / OE
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