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