Job Description for Change control position:
Responsibilities:
- Support life cycle documents and execution.
- Management and support of change controls necessary for the projects and its lifecycle through process Compliance and interface with Quality Assurance change control area.
- Author/Draft change control documents ( e.g technical evaluations, etc) for review and approval.
- Author validation life cycle documents for client review and approval.
- Route drafted documents for review. Request approval workflows to Doc Control.
- Route reviewed documents for workflow approval.
- Request performance copies for protocols.
- Execute approved protocols.
Qualifications:
- Bachelor's/ master's degree or equivalent in a scientific or health care field.
- 8-10 years of experience as a Senior Validation Analyst/ Lead preferably in the pharmaceutical /Life sciences industry preferred.