Director International Audit and Compliance
An international pharmaceutical company is advertising a vacancy for a Director International Audit and Compliance to their office in the UK. This company specialises in developing and commercialising innovative medicines for the treatment of unmet therapeutic needs in major western markets. Based in the south of England, this position is an exciting opportunity to bolster a career in the QA field, developing and executing GXP audit strategies for the EMEA region.
- Ensure audit strategies and audit plans are developed and executed in timely fashion.
- Ensure that due diligence audits, routine audits of suppliers, service providers, and affiliates, and self-inspections are conducted.
- Ensure that key risks highlighted to Senior Management in timely manner.
- Ensure CAPA identified during the audits are implemented as per SOP.
- Work collaboratively with senior team and support them as required in contractor risk assessments and other day to day QA operations.
- Carry out GXP training.
Skills and Requirements:
- A Life Science degree or equivalent.
- At broad experience of working within the Pharmaceutical industry of which several years should have been in a QA auditing.
- Excellent working knowledge of international GxPs, especially in the interpretation of MHRA and FDA requirements, for the manufacture, control and distribution of commercial product and clinical trial materials.
- Sound knowledge of the principles of solid and semi-solid dosage manufacturing processes (Tablets, capsules, gels, creams, ointments, injectable etc.).
- Sound knowledge of QC and Stability chemical analytical testing techniques for solids and semi solids.
- Familiar with the regulatory requirements for validation activities as applied to manufacturing and packaging processes, analytical methods, cleaning procedures, and computerised systems.
- Familiar with the appropriate EU Directives, EU and USA regulatory processes, ICH Guidelines.
- Familiar with Quality Management Systems e.g. ICH Q10.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Katty Maia at +44 2038543317 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. Proclinical Staffing is an equal opportunity employer.