Validation & Laboratory Services Specialist – Maternity Leave
Join Merck Healthcare as a Validation & Laboratory Services Specialist for a maternity leave.
Responsibilities
Collaborate in drafting and reviewing documents (e.g., Validation Plan, Risk Analysis, Traceability Matrices, System Description) and qualification protocols for Computer Systems and/or Equipment.
Review, execute, and document tests for the validation of Computer Systems in accordance with internal procedures and the requirements of 21 CFR part 11 and/or Annex 11.
Draft and issue Validation Summary Reports and/or qualification reports.
Review protocols and reports for validation, calibration, and maintenance.
Update and maintain the risk analysis.
Ensure compliance with GMP regulations for departments operating in controlled environments.
Draft and update SOPs related to the group.
Perform all necessary operations to ensure calibration, validation, and maintenance of laboratory equipment within the timeframes and methods stipulated by current GxP procedures.
Promote activities related to ISO certifications, ensuring compliance with constraints and references.
Qualifications
One to three years of experience managing and producing documents (protocols and reports) on validation and calibration activities for instruments and computerized systems.
Good knowledge of SAP (calibration, maintenance, and validation modules).
Excellent written and spoken knowledge of English and Italian.
Excellent knowledge of the Office suite and use of Project.
Excellent knowledge of GMP.
Excellent knowledge of the requirements of 21 CFR part 11 and/or Annex 11 for CS in GMP contexts.
Good presentation skills during inspections.
What we offer
We are committed to inclusion, diversity, and flexibility, providing opportunities for personal development and career advancement across the globe.
Apply now and become a part of a team dedicated to sparking discovery and elevating humanity!
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