R.T. Lane Recruitment

€39 ~ €50 per hour. Initial 12-month contract.

Position Description

To provide support for the validation activities associated with equipment, reagents, facilities, cleaning, test methods, and environment ensuring that all compliance issues and requirements of our clients Validation Policies and Procedures are addressed.

 Primary Tasks and Responsibilities

Managing Complexity/Technical Accountability Serves as technical expert for the Validation process and responsibilities to ensure compliance Continuous Learning/Managing Risk Resolves & manages technical operational problems in area of expertise Suggest and sometimes may implement innovation and continuous improvement within the Validation process Implements initiatives in the Validation Process that will deliver customer value at lowest cost.

Facilitates successful team behaviour within Quality Systems and across functional areas Manages relationships externally and internally. Builds cross functional and cross-departmental support, fostering overall effectiveness fosters harmony within Quality Systems. Influences and persuades so as to bring about technical and process improvements. Ensure accuracy and maintenance of the clients Validation Master List. Review and approve Validation Master Plans, Protocols, Summary Reports and other documentation associated with validations, as appropriate for each validation exercise. Ensure all validation activities and documents are authorised and appropriate compliance approval is gained. Ensure that all validation activities are carried out and reported in a timely manner. Ensure compliance through assisting in audits. Through effective communication and training initiatives develop staff in projects and validation teams to ensure that validation projects are carried out in accordance with the clients Policies and Procedures.

Requirements:

  • Knowledge of bespoke validation, process knowledge and documentation.
  • High understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations.
  • Working experience of validation computer systems for use in an FDA regulated environment.
  • Must be able to lead and give direction to Validation Projects and Teams.

Methodology/Certification Requirements:

  • Level 8 degree in an engineering or science discipline with a broad technical/educational skills base.
  • Minimum of 3 years working in a regulated environment, 2 which have been spent carrying out validation and/or testing activities.

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