Meta Resources Group
Clinical Systems IT Validation Manager
Meta Resources Group, Blacklick, Ohio, United States, 43099
Job DescriptionOur client, a global pharmaceutical company, is seeking a clinical systems validation manager to set strategy and policies and oversight of the Validation Department and programs of related activities.
This role is onsite in Columbus, Ohio and will be a 1 year contractual position with the likelihood of renewal.
Job Description:
Manage staff and workload of the validation team. Provide coaching, training and mentoring for routine and complex activitiesDevelopment and implementation of strategy and policies related to validation.Development and oversight of the execution of validation related documents throughout the system, including development of a comprehensive validation master plan covering equipment, utilities, sterilization, cleaning, aseptic processing, cleanroom qualification and computerized system validationSupport change control, investigations, and MBR's and SOP's updatesDetermine levels of importance or risk to be assigned to elements under review to ensure validation efforts are directed at the systems which have the potential to impact product quality, efficacy, and data integrity using a variety of toolsRepresent the validation group and defend policies, program, and validation documentation during audits, regulatory inspectionsDevelop and co-approve GxP documents including, but not limited to, Master Validation Plans, SOPs, IQs, OQs, PQs, protocols and forms to improve validation efficienciesIs knowledgeable and complies with all pertinent safety policies, rules and regulationsEnsure that all team members comply with safety rules and regulationsMaintenance of quality systems and GxP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participatesCollaborate with cross functional team members and meet deadlines for various validRequirements
At least 5 years experience Validation Management experience ideally within the clinical, medical, laboratory or pharmaceutical industryGood understanding and application of GMP and regulatory requirementsExperience of wide range of validations including Computer Systems Validation, equipment, cleaning and utility and facilities validation plansExcellent communication skillsPreviously managed or supervised a team of experienced engineers in a similar industry
This role is onsite in Columbus, Ohio and will be a 1 year contractual position with the likelihood of renewal.
Job Description:
Manage staff and workload of the validation team. Provide coaching, training and mentoring for routine and complex activitiesDevelopment and implementation of strategy and policies related to validation.Development and oversight of the execution of validation related documents throughout the system, including development of a comprehensive validation master plan covering equipment, utilities, sterilization, cleaning, aseptic processing, cleanroom qualification and computerized system validationSupport change control, investigations, and MBR's and SOP's updatesDetermine levels of importance or risk to be assigned to elements under review to ensure validation efforts are directed at the systems which have the potential to impact product quality, efficacy, and data integrity using a variety of toolsRepresent the validation group and defend policies, program, and validation documentation during audits, regulatory inspectionsDevelop and co-approve GxP documents including, but not limited to, Master Validation Plans, SOPs, IQs, OQs, PQs, protocols and forms to improve validation efficienciesIs knowledgeable and complies with all pertinent safety policies, rules and regulationsEnsure that all team members comply with safety rules and regulationsMaintenance of quality systems and GxP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participatesCollaborate with cross functional team members and meet deadlines for various validRequirements
At least 5 years experience Validation Management experience ideally within the clinical, medical, laboratory or pharmaceutical industryGood understanding and application of GMP and regulatory requirementsExperience of wide range of validations including Computer Systems Validation, equipment, cleaning and utility and facilities validation plansExcellent communication skillsPreviously managed or supervised a team of experienced engineers in a similar industry