Validation & Laboratory Services Specialist Maternity Leave

Merck Healthcare; Guidonia Montecelio; In loco; EUR 70.000 - 90.000; Tempo pieno

Descrizione del lavoro

A leading healthcare company in Guidonia Montecelio is seeking a Validation & Laboratory Services Specialist for a maternity leave position. Responsibilities include drafting and reviewing validation documents, executing tests, and ensuring compliance with GMP regulations. Candidates should possess 1-3 years of experience in validation and calibration documentation, technical knowledge of SAP, and proficiency in both English and Italian. This position offers opportunities for personal development and being part of a diverse team committed to innovation.

Servizi

Opportunities for personal development

Career advancement

Competenze

• 1-3 years of experience managing validation and calibration documents.
• Technical proficiency in SAP, particularly in calibration and validation.
• Ability to communicate effectively in written and spoken English and Italian.

Mansioni

• Draft and review validation-related documents like Validation Plans and protocols.
• Execute tests for validation in compliance with established procedures.
• Generate Validation Summary Reports and maintain risk analysis.

Conoscenze

Document management on validation and calibration

Knowledge of SAP

Bilingual in English and Italian

Office suite proficiency

Understanding of GMP

Knowledge of 21 CFR part 11

Presentation skills

Descrizione del lavoro

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!