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IT Validation Specialist

vor 2 Monaten


Köln, Nordrhein-Westfalen, Deutschland Redcare Pharmacy Vollzeit

About Redcare Pharmacy:

We are a leading pharmacy company dedicated to providing high-quality healthcare services to our customers. As a key member of our team, you will play a crucial role in ensuring the accuracy and reliability of our IT systems.

About the Role:

We are seeking an experienced IT Validation Specialist to join our team. As an IT Validation Specialist, you will be responsible for developing and implementing validation strategies for our software engineering teams. This will involve collaborating with cross-functional teams to ensure seamless integration into agile software development cycles.

Key Responsibilities:

  • Develop and implement validation strategies for software engineering teams, ensuring alignment with internal policies and procedures.

  • Assist in creating validation plans, protocols, and reports that meet internal Standard Operating Procedures (SOPs).

  • Support product validations, including requirements collection, risk assessment, test scripts, results, and communication of corrective actions.

  • Develop and update internal company procedures and policies that translate regulatory standards into actionable procedures.

  • Perform internal trainings and audits to ensure deep understanding and correct implementation of validation practices across software engineering teams.

Requirements:

  • Experience in working with standards and deep knowledge of one of the following regulations: GAMP5, ISO13485, IEC62304, FDA 21 CFR Part 820, ISO14971, IEEE 829.

  • Experience in the validation of IT systems is a must.

  • Previous experience in working in a GDP environment.

  • High sense of responsibility, quality awareness, and initiative.

About Your Benefits:

We offer a wide range of benefits to support our employees' individual needs, including:

  • Sports: Enjoy a membership package at Urban Sports Club, offering a variety of sport options.

  • Mental Health: Access quick and professional help from psychologists at Likeminded, available anonymously and free of charge.

  • Work from Home: Flexible work arrangements, including up to 20 days a year, anywhere in the EU.

  • Mobility: Receive a fully costed Deutschland Ticket for travel within the EU.

  • Personal Development: Grow with us through various in- and external trainings.