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Senior Validation Manager
hace 3 meses
Job Title:
Validation ManagerLocation: Barcelona, Spain
Job Type:
Permanent Job Description We are seeking a highly motivated and experienced Validation Manager to join our team, providing expert services to a leading pharmaceutical client
Main tasks and responsibilities:
Develop and document validation strategies for complex projects, considering both business needs and regulatory requirements (GxP, FDA, etc.).Define and implement validation approaches to meet project specifications, collaborating with the client's internal Quality department.
Lead and coordinate the validation process, effectively communicating and negotiating deliverables with stakeholders.
Prioritize tasks and manage time effectively to ensure timely project completion.
Present and defend validation concepts to compliance offices and regulatory authorities during audits and inspections.
RequirementsBachelor's or Master's degree in IT, engineering, sciences, pharmaceuticals, biotechnology, or a related field.
Strong understanding of analysis and user requirement engineering methods.
Excellent written and verbal English communication skills.
Experience in project implementation using computer validation regulations and methods (SOPs, GCP, FDA Guidelines, CFR 21 Part 11) and data integrity principles.
Passion for teamwork and fostering collaboration in diverse technical and cultural environments.Prior experience with Agile methodologies is a strong asset.#J-18808-Ljbffr
