A Validation Manager required by CareerWise Recruitment for our Mayo based client. If you have People Management & Biologics experience then this is the job for you !!!
Role of this position
- Responsible for the coordination of all Validation activities at the Mayo site.
- Site Subject Matter Expert for the validation function
- Manage the Validations Team on a day-to-day basis, identify training requirements and develop the skillset within the group to support operations relating to validation.
- Develop individual goals and objectives for validation team members to support personal and company goals.
- Represent the Validations Department in regulatory (FDA/HPRA) and client audits as required.
- Ensure adherence to the site Validation Master Plan in all activities performed by the Validation Department.
- Accountable for writing, executing & reporting of all validation activities including but not limited to (FAT / IQ / OQ / PQ / FMEA Risk Assessments/ PVP).
- Supporting the Validations team in completing any deviations/out of limits encountered during validation projects and implementing effective CAPA actions.
- Coordination of on-site Validation Contractor Activities to ensure adherence to EH&S and Quality systems requirements.
- Work closely with other Departments and the Quality Department to ensure the operation of a validated environment according to GMP and other regulatory requirements
- Technical review and approval of Validation documents submitted by the validations team or external vendors.
- Be a team member for Capital projects involving Validation deliverables identified by site management.
- Maintenance of key site Validation documents to include Validation Master Plan, Equipment and Process Validation Master Plan, Validation Department SOP's, Site Re-Qualification Schedule.
- Ensuring that all site validation equipment (Data Loggers, Hot Blocks, Pressure Transducers etc) are regularly calibrated and certified for use.
- Coordinate and communicate the Validation schedule to site management on a regular basis.
- Bachelor's degree in Science, Engineering, Technology or a related discipline
- Minimum of 3 years' experience as a validation engineer/specialist in a cGMP environment preferably in the Medical Device/Pharma Industry.
- Proven track record of managing people
Please call Louise Mulligan today for further information on 0949003979 or email: firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)