Darwin Partners' Validation Practice currently has an exciting opportunity with a Fortune 1000 company that is on the leading edge of the medical products industry. This company is currently looking for a Senior LIMS Validation Manager to lead the validation activities for a global LIMS program to comply with all applicable FDA and local regulations.In addition to leading the validation effort for the global LIMS program you will also be responsible for defining all activities and measures to ensure compliance with all applicable regulations. You will work with the Quality Organization to obtain required approvals for all quality systems-related documents (e.g. User Requirements, Specifications, Assessments, Qualification Plans, Validation Report, etc.). Other responsibilities will include coordinating and supervising the creation and execution of test case
s as well as providing validation template packages to local validation teams to standardize the approach for local system implementations.
The ideal candidate for this opportunity will possess:
- 10+ years of experience in pharmaceutical system validations and operation within pharmaceutical quality systems (GMP, GCP, GLP, and QSR).
- 7+ years of experience in the pharmaceutical or other FDA regulated industry.
- 5+ years of demonstrated project management experience.
In your response, please speak directly towards your LIMS experience.
Please respond to [email protected]
