Lead Quality Inspector

Job Description

OBJECTIVES/PURPOSE:

• Supervises and knows the activities within their competence, which they coordinate and control through the guidance of the VI Shift leaders.
• Ensures that the activities are carried out in compliance with clear and defined operating procedures to ensure that the process/product is executed/manufactured according to equally defined quality criteria.
• Ensures compliance with EHS regulations during their working hours for the entire department.
• Is responsible for ensuring the achievement of the production volume targets set by the Supply Chain.
  

ACCOUNTABILITIES:

• Guarantee compilation of the Production Program in accordance to the previously established Plant targets defined in Budget and Forecast (MPS/LT Fulfilment)
• Coordinates the visual inspection of unlabeled product and Media Fill according to the reference SOPs.
• Organizes the qualification operations of the VI personnel. Coordinates training and development plan of direct and indirect reports
• Participates in managing the review of procedures, training, activities related to opening and investigating events, validations, and Change Control in visual inspection.
• Is responsible for meeting the business KPI in terms of VI process timelines, communicating any delays, and adjusting the VI production plan accordingly.
• Coordinates the VI personnel and plans their activities to meet the production plan and conduct training; is responsible for evaluating the performance of their subordinates.
• Is responsible for interactions within the network and global programs related to Visual Inspection.
• Guarantee the respect of preventive/corrective maintenance operations, validation, and calibration activities on production equipment related to Crude Fractionation area;
• Ensure that Visual Inspection personnel correctly complete production batch records and generally all Visual Inspection related documentation is correctly and timely prepared;
  

WHAT YOU BRING TO TAKEDA:

• Bachelor's/Master's degree in Chemistry, Pharmaceutical Chemistry, Biology, or related field
• Knowledge of cGMP. Previous experience in Team Management and at least 5 years in the pharmaceutical field
• Knowledge of the visual inspection process of Albumin
• Knowledge of Visual Inspection regulations
• Ability to interpret and modify the production program.
• Knowledge of MBRs and SOPs in the VI department
• Knowledge of key leadership behaviors
• Communication, Influential and presentation skills
• Digital/innovation oriented
• Good knowledge of the English language