Senior Quality Assurance Engineer
An international pharmaceutical company is currently recruiting a Senior Quality Assurance Engineer to their office in Singapore. The organisation offers a full range of consulting, development, and commercialisation services across 37 countries, with a global team of experts that have extensive experience across a broad range of therapeutic areas. This is an exciting opportunity to work with a dynamic and innovative establishment that accelerates the development of drugs and devices that save lives and improve patient's quality of life.
- Planning and conducting internal and external QA Audits, both regular and at random, in order to assure that clinical studies are of the highest standard and are in compliance with the requirements of SOPs, study protocols, relevant regulations and guidelines, and ISO 9000 requirements.
- Preforming contract audits for Sponsor companies are required.
- Ensuring that audit results are formally recorded and reported and that corrective/preventative actions are documented.
- When appointed lead auditor, performing the duties assigned in an efficient and effective manner. This includes liaising with the project manager on all QA issues, including audit planning and review of audit results.
- Assisting with the development of the project audit procedures.
- Assisting in training new QA auditors.
- Assisting in training company staff regarding GCP, ISO 9000, role of QA, regulatory inspections etc.
- Conducting induction/orientation of new staff in company quality policies and procedures.
- Assisting with business development activities (such as marketing presentations) when appropriate.
- Providing a benchmark of auditing competencies to inexperienced colleagues.
- Assuming additional QA responsibilities as directed by QA manager.
- Keeping the person whom the QA auditor reports to informed of any QA issues within the department that require attention.
- Travel is approximately 35%
Skills and Requirements:
- Bachelor's Degree or local equivalent in medicine or science.
- Background in medicine, science and/ or other relevant discipline and appropriate experience.
- Previous experience in 1+ years of Quality Assurance auditing
- Detailed knowledge of GCP guidelines and relevant regulations for the conduct of clinical trials.
- Knowledge in either DM or Biostats would be a plus.
- Ability to review and evaluate clinical data/ records.
- Ability to successfully implement quality plans for specific phases of a trial.
- Ability to liaise with project teams.
- 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 Mandy Fang at M.Fang@proclinical.com.sg or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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