Compliance Specialist

Job Title: Compliance Specialist Location: Ware, UK Duration: Permanent Work Experience : GMP experience Proficient knowledge of international Pharmacopoeias and recent changes Experienced in managing analytical related change control and related CAPAs Experienced in method qualification, development and validation and authoring related documents Experienced in QC testing related to the testing of raw materials including techniques such as GC and/or HPLC, titration, and general Pharmacopoeia wet chemistry techniques.
Experience in documentation authoring, reviewing and approval to enable efficient and compliant testing for worldwide markets (USP/PhEur/JP/ChP).
Requirements: Relevant Bachelor of Science Degree (for example Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Forensics) or equivalent, with minimum 3 years practical work experience.
Proficient knowledge of international Pharmacopoeias and recent changes Experienced in managing analytical related change control and related CAPAs Experienced in method qualification, development and validation and authoring related documents Experienced in QC testing related to the testing of raw materials including techniques such as gas chromatography, titration, and general Pharmacopoeia wet chemistry techniques.
Is highly proficient in key analytical skills including laboratory instruments, software packages and other analytical techniques.
Is proficient in problem solving and has expertise in troubleshooting analytical equipment.
Is competent in application of statistical and mathematical tools and formulae and can derive formulae for analytical methods from first principles.
Understands purpose of all techniques applicable to dosage form Is competent in the use of basic Lean Sigma tools, and can lead "JDl's", and aware of the Quality Management System and 6 management principals