Validation & Quality
Validation & Quality
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Responsibilities:
- Create and support review of validation life cycle documents for Analytical Instrument Qualification and computerized systems.
- Experience in validation of analytical instrument systems (e.g. benchtop analytical systems spectroscopy chromatography protein analyzers next gen sequencers PCRs etc.).
- Consult clients on data integrity requirements in Analytical Instruments and perform verification of DI in the systems.
- Author validation life cycle documents for clients review and approval.
- Route drafted documents for review.
- Route reviewed documents for workflow approval.
- Request approval workflows to Doc Control.
- Execute approved protocols in GxP facility.
- Understand SDLC process and SDLC methodology such as agile etc.
- Work with different stakeholders (IT Network Vendor) team in delivering validation project deliverables.
- Manage change controls necessary for project life cycle through process compliance and interface with Quality Assurance change control area.
- Author change control documents for client review and approval.
Requirements:
- Bachelors/ Masters degree or equivalent in a scientific or health care field.
- Prior experience with benchtop instrument experience is a must.
- 5 years experience in a Validation/ Quality assurance / control role preferably in the pharmaceutical /Life sciences industry preferred.
Employment Type
Full Time
