As a GCP/CSV audtior, your role will be to provide an important overview role by auditing and assessing projects, suppliers and processes, following your research you will produce and report the results. Auditing experience around CSV is a must have.
- Providing quality input to projects
- Performs quality reviews of project deliverables to ensure that all products are released with levels of quality that meet and exceed customer expectations.
- Schedule, plan, conducts and, reports audits and audit results for internal and external audits including off-site supplier audits.
- Manage the Non-Conformance / Corrective Action processes from inception, root cause analysis, and closure in general and particularly for audits conducted.
- Bachelor Degree, quality certification or equivalent experience as determined by the hiring manager.
- Minimum 2 years or more of relevant industry experience or equivalent education/training.
- Training or education in quality assurance / control activities including GCP and/or computer system validation.
- Familiarity with 21 CFR Part 11 ERES and EU Annex 11 regulations.
- Understanding of the pharmaceutical industry preferably with clinical trial or GxP experience.
- Familiarity with or ability to learn ISO standards ISO 9001, ISO 12207, ISO 27002, and ISO13485 is preferred.
Vivid Resourcing are committed to equality of opportunity for all applications from individuals are encouraged regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships or any other characteristic protected by law.
This job was originally posted as www.totaljobs.com/job/80698359