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
