KEY RESPONSIBILITIES:

· Contribute on the preparation and review of the Validation Master Plan – Process and Cleaning

· Manage the validation requirements of Chanelle and third party suppliers and CMO’s

· Manage the preparation, review and issuing of Validation Protocols and Reports (this to include equipment, cleaning, process and computer system validation)

· To maintain and take responsibility for the cleaning validation strategy at Chanelle

· To assume responsibility for the cleaning validation master plan confirming to accepted practices and demands of the competent authorities in the EU

· Implementation of Process Validation of new products for regulatory submissions ensuring compliance to proposed registered specifications

· Coordination of the execution of Validation in accordance with protocols by Production, Quality Control and R&D teams

· Establishing, implementing and directing validation and revalidation activities

· Liaise with contract manufacture customers in seeking their approval for protocols and reports where appropriate

· Reviewing and managing Change Control Forms for Validation implications

· Reviewing and managing Non-Conformances for Validation Implications

· Updating existing quality documentation related to validation activities

· Identifying training requirements in support of validation

· Ensuring completion of validation protocols

· Carry out Internal Audits as required

· Responsible for the execution of Risk Assessments or Investigation reports relative to the role

· Maintaining validation documentation system

· Required to Lead cross functional teams providing knowledge in resolution in any technical issues

· Assisting in the preparation and hosting of associated regulatory and customer audits