Description
We are looking for an
IT Quality Reviewer (m/f)
Referenz: -en
Beginn: 10/13
Dauer: 15 MM++
Ort: in the Basel region
Branche: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Ihre Aufgaben:
- Implement quality procedures and provides quality support and guidance to the Drug Safety Informatics team for the development and operation of computerized systems
- Ensure that the applicable regulations, guidelines and internal procedures related to validation of computer systems are followed and applied during all stages of the defined software development life cycle (SDLC) and project phase activities
- Analyze the validation impact of changes and help in formulating the validation strategy for changes to existing or new computer systems
- Review and provide input to SDLC documentation including testing and other validation deliverables
- Support system lifecycle processes such as change control and document management
- Provide training related to computerized systems quality and compliance
- Assist in resolving and documenting technical and project-related issues
Ihre Qualifikation
- Long-term commercial validation experience in a GxP environment in the biotech or pharmaceutical industry
- Formal training and proficiency in software development methodologies and computer systems validation in regulated industries (biotech/pharma)
- Preferably experience in cloud-based validation, in particular Salesforce.com
- Expertise in interpretation of the applicable regulations that impact computer systems (e.g. 21 CFR Parts 11, 50, 58, 312) used in GxP environment and related FDA guidelines, regulations, as well as ICH GCP guidelines
- Application of industry guidance and best practices regarding the validation and documentation of computer systems (e.g. GAMP)
- Experience in Drug Safety systems validation and with working in global teams is a plus
- Fluent spoken and written English
Skills:
- Auditor
Keywords: Auditor IT Quality Reviewer CFR Validation Cloud Regulated Pharma Druf Safety sdlc analyst