PERSONAL SPECIFICATIONS QUALIFICATIONS Master s degree in Life Sciences 3 years of cGMP experience in Validation Or Bachelor s degree in Life Science 5 years of cGMP experience in Validation EXPERIENCE Leading motivating and negotiating with cross functional teams Excellent knowledge of and experience with GMP processes involved in qualification of facility utility equipment and validation of computer systems shipping cleaning test methods and manufacturing processes Participating in regulatory audits i e MPI ACVM FDA MEDSAFE TGA Strong computer operation skills including word processing adobe visio presentation database and spreadsheet application skills Excellent technical writing and communication skills in English Maori an asset facilitation and presentation skills SKILLS AND APTITUDE Proficiency with qualification and validation Extensive knowledge and application of GMP Qualification and Validation regulations and standards e g PIC S MPI MEDSAFE TGA FDA pertaining to the production of pharmaceutical veterinary products and ability to evaluate compliance issues Confident ability to interact with regulatory agencies both orally and in writing Advanced root cause data analysis and skills in solving complex problems Elevates issues to management when appropriate Strong team player able to focus on departmental goals whilst respecting the needs of others Able to work independently as well leading teams and effectively interacting with various levels Advanced skill in handling multiple responsibilities tasks and projects simultaneously including ability to shift priorities and follow assignments through to completion Must be able to handle multiple projects concurrently POSITION DETAILS REPORTS TO Head of Quality DEPARTMENT Technical Quality Assurance PURPOSE The primary responsibility for this position will be establishment and execution of the validation strategy to provide documentary evidence demonstrating that facility utility equipment qualification as well as computer systems shipping cleaning test method and process validation carried out maintains the desired level of compliance WORKING RELATIONSHIPS All staff SPECIFIC DUTIES Leads teams Determines actions necessary to accomplish site quality objectives Facilitates cross functional teams to accomplish deliverables milestones and objectives meeting the plans and schedules ensuring that any change to the plans is communicated to and agreed by the teams and project sponsors Coach employees as necessary to meet technical and GMP Systems standards Provide training for staff Ensure all Quality Systems qualification and validation activities are performed according to relevant Standard Operating Procedures SOP s and Work Instructions WIs which are accurate and within their review dates as well as initiating changes to Procedures Lead the following Quality principal duties Ensure good housekeeping and 5S methodology is applied to the work area Provide quality oversight of facilities utilities equipment shipping cleaning method process and computer validations in a cGMP environment on site and with contractors Maintain validation master plan status report including regulatory commitments Execute validation to the schedule for both the site and customers Submit quote to Finance Controller for customer requests for process method cleaning validation Review and approve validation documentation and change controls as well as provide input for GMP validation activities against regulatory requirements Apply 5S methodology Lead and represent Quality Validation in project teams such as technology transfer Manage and coordinate process monitoring and continuous improvement initiatives as related to validation master plans per GMP requirements Development and implementation of SOPs Guideline documents with systemic procedural improvements related to validation activities Preparation generation execution and final package preparation for protocols required for qualification and validation activities Review and approve qualification and validation summary reports Review and approve change controls for validation impact related to the implementation of facility utility equipment process changes method improvements and computer systems Identify roadblocks and barriers develop resolutions and know when to communicate them provide clear communication to team members to meet project expectations analyse data evaluate results form conclusions recommend equipment and or process improvements Present key issues related to product quality to Quality Management Develop others knowledge of GMP regulations and guidance within the organisation through training on validation topics Mentor personnel in the organisation as requested by the Head of Quality Perform other Quality duties as assigned and other GMP activities as needed Support Data Integrity reviews at the site Perform gap analysis of Quality Systems to new and existing regulations and standards Provide metrics and Key Performance Indicators KPIs for management of risks and compliance
