Quality Assurance Specialist
3 settimane fa
About the Role:
As a Visual Inspection Lead at Takeda Pharmaceutical, you will be responsible for overseeing and managing activities within the scope of visual inspection. This includes coordinating and controlling these activities through the guidance of VI shift leaders, ensuring that all tasks are carried out in strict adherence to clearly defined operating procedures. Your goal will be to guarantee that processes and products meet established quality standards, while also ensuring compliance with EHS regulations throughout your working hours across the entire department.
Key Responsibilities:
- Guarantee the compilation of the Production Program in accordance with the previously established Plant targets defined in Budget and Forecast (MPS/LT Fulfilment)
- Cordinates the visual inspection of unlabelled 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.
- 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.
About You:
To be successful in this role, you will need to have a Bachelor's/Master's degree in Chemistry, Pharmaceutical Chemistry, Biology, or a related field. You will also need to have knowledge of cGMP, previous experience in Team Management, and relevant years in the pharmaceutical field. Additionally, you will need to have knowledge of the visual inspection process of Albumin, knowledge of Visual Inspection regulations, knowledge of MBRs and SOPs in the VI department, communication, influential, and presentation skills, and a good knowledge of the English language.
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