Key Responsibilities:
- Conduct analyses on lab samples, raw materials, and specialized samples using chemistry and biochemistry techniques.
- Ensure assigned tests are executed promptly and in adherence to Standard Operating Procedures (SOPs).
- Perform regular calibration and maintenance of laboratory equipment.
- Review and approve QC records and logbooks.
- Track and analyze lab results for trends.
- Initiate and participate in investigations for Out of Specification (OOS) results, invalid tests, and laboratory deviations, aiding in the timely closure of lab investigations and Corrective and Preventive Actions (CAPAs).
- Develop and update SOPs, forms, training qualifications, and risk assessments.
- Provide technical support for troubleshooting lab-related issues, such as equipment malfunctions or method inconsistencies.
- Ensure safe handling, disposal of waste, and a secure working environment.
- Maintain 6S standards and ensure cleanliness within the analytical lab.
- Support Operational Excellence initiatives, including GEMBA and GMP inspections.
- Participate in projects aimed at enhancing safety and promoting continuous improvement.
- Assist the Supervisor during internal and external compliance audits.
- Follow Environmental Health and Safety (EHS) requirements of the site.
- Uphold fair and respectful relations with colleagues, adhering to Takeda’s Code of Conduct.
- Perform other duties as assigned by the Supervisor.
Education and Experience Requirements:
- Bachelor’s degree in Chemistry, Biochemistry, Biotechnology, or a related field, with preferably 2-4 years of experience in the pharmaceutical, biopharmaceutical, or related manufacturing sector.
Technical Skills:
- Proficiency with laboratory equipment.
- Familiarity with Empower and Laboratory Information Management Systems (LIMS).
- Competency in Microsoft Office applications.
