A leading biopharmaceutical company, which develops and commercialises medicines in Oncological, Neuroscience, and Rare Disease fields, is currently recruiting for a Senior GxP Quality Auditor - GMP/GDP. This company boasts an extremely impressive portfolio of therapies for prostate cancer, neuroendocrine tumours, and renal cell carcinoma, along with medicines for cervical dystonia, hemifacial spasm, and paediatric lower limb spasticity. Based in the company's Swiss office, this role is an exciting opportunity to bring experience and dedication to this internationally successful company.
Job Responsibilities:
- Perform regular and random QA audits of clinical trials.
- Become involved, when required, in project audit management and staff training and contribute to the review of company systems and procedures as appropriate.
- Effectively plan and conduct regular and random QA audits (internal and external) in order to assure that clinical studies comply with the requirements of company SOPs, study protocols, relevant regulations and guidelines, and with ISO 14155 requirements.
- Perform quality system audits as required.
- Ensure that audit results are formally recorded and reported and that corrective/preventive actions are properly completed and documented.
- Assist with the development of project audit procedures for audits that are related to clinical operations (internal audits, Investigator site audits, clinical vendors etc.).
- Assist in training company staff regarding GCP, ISO 14155, MEDDEV, CFR, role of QA, regulatory inspections etc..
- Conduct induction/orientation of new staff in company quality policies and procedures.
- Assist with the co-ordination of Regulatory inspections and assist at such audits as necessary.
- Carry out a consultant role for the global Clinical QA department, including project support, SOP preparation and review, and implementing CAPA.
- Keep the line manager informed of any QA issues within the department that require attention.
Skills and Requirements:
- Degree in Medicine, Technical/Scientific Studies, or equivalent.
- 5 plus years of Clinical Quality Assurance experience in a Pharmaceutical, preferably in a Medical Device regulated environment.
- Proven Auditing experience and experience with regulatory inspections.
- Knowledge of regulations for Medical Devices, especially EN ISO 14155, ICH-GCP.
- Fluent English is a must-have, German is an asset.
- Willingness to travel at least 40% of time (international and domestic).
- 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.
To Apply:
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 Valaince Penteng at +44 203 846 0643 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.
Proclinical Staffing is an equal opportunity employer.
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