This role has accountability for the management and execution of all calibration activities and laboratory systems qualification programmes on site, including operations, utilities, and site laboratories. The role holder must have a strong working knowledge of GxP systems and requirements and must ensure all equipment is maintained in its validated state. Excellent planning ability and communication are essential requirements as is the ability to collaborate cross-functionally and with external contractors to ensure all timelines are met consistently

Essential Functions/Responsibilities

• Support of equipment installation and qualification along with associated documentation generation, review in accordance with all quality and regulatory expectations.
• Serve as a subject matter expert and point of contact for site instrumentation metrology.
• Identify and harmonize practices across the Jazz network in relation to metrology.
• Liaise with external calibration/equipment maintenance providers to ensure adherence to calibration, periodic maintenance, and qualification schedules.
• Provide Instrumentation/Calibration support to Facilities, Quality Assurance Team, Engineering and Operations.
• Maintaining site instrumentation in validated state to support GMP testing activities in accordance with site schedules and company policies, procedures, and guidelines.
• Liaise with external calibration/equipment maintenance providers to ensure adherence to calibration, periodic maintenance, and qualification schedules.
• Raise deviations and lead investigations to closure as per site procedures.
• Raise and take ownership of change controls as per site procedures.
• Development of site Calibration and equipment SOPs, protocols and reports as required
• Compiling reports on monthly metrics internally and presenting out to relevant stakeholders
• Stay current with client, EU, FDA and GAMP validation expectations, regulations, and requirements; interpret regulations and coordinate implementation into internal practices
• Establishing calibration tolerances and test points for all identified items.
• Management of the Calibration Budget.
• Procurement of Calibration Reference Standards for the testing of instruments
• Responsible for complying with ‘general duties of employees’ regarding to safety, health and welfare in the workplace as outlined in Section 13 of the Safety, Health & Welfare at Work Act, 2005.
• Employees have a duty to take reasonable care to protect their own safety, health and welfare in the workplace and make use of any personal protective equipment provided to protect their own health and safety.
• Employees are also responsible for reporting to management, accidents and near misses, any unsafe work, unsafe conditions, including defects that may endanger the safety of employees at work.

Required Knowledge, Skills, and Abilities

• Strong experience of working within a GxP environment
• Knowledge and experience of working to standards such as ISO 17025
• Ability to troubleshoot problems and identify root causes
• Ability to act as an SME in internal and external audits
• Good Technical writing ability
• Have the ability to troubleshoot, and startup of instrumentation.
• Have the ability to calibrate various types of instrumentation including temperature, pressure, level, flow and analytical instruments.
• Excellent organizational skills

Required/Preferred Education and Licenses

• A bachelor’s degree in science or engineering, preferred, along with 2+ years of experience in a similar position or Qualified to National Craft Standard, 5+ years of field experience in a relevant area.