Technical Operations Officer

**Job Description:** **Role Overview:** You will be responsible for reviewing executed PI Sheets for accuracy and completeness. Working closely with the QA team, you will address any queries raised by clients or internally. Collaborating with Senior Technical Operations Officers, you will ensure timely completion of actions resulting from change control. Additionally, you will coordinate with the document control team to request PI sheets before the Manufacturing start date and work with Shift team leaders for necessary label printing. Your role will also involve updating cleaning and buffer PI sheets, aiding in investigations related to process deviations, and collecting data for end-of-campaign reports. Moreover, you will review and update SOPs, OIs, and PI sheets, while providing support to Senior Technical Operations Officer on project-specific tasks. You will also contribute hands-on support for FAT/SAT, ensuring training and documentation for operational optimization. **Key Responsibilities:** - Review executed PI Sheets for accuracy and completeness - Collaborate with QA to address client and internal queries - Work with Senior Technical Operations Officers on change control actions - Coordinate with document control team for timely PI sheet requests - Ensure required labels for manufacturing are printed as needed - Update cleaning and buffer PI sheets - Assist in investigations of process deviations - Collect data for end-of-campaign reports - Review and update SOPs, OIs, and PI sheets - Provide hands-on support for FAT/SAT and create training documentation for operational enhancement **Qualifications:** - Degree in a scientific subject or equivalent GMP experience - Good chemical/bio-processing industry knowledge - Strong understanding of GMP and chemical unit operations - Experience in updating and creating batch record documentation - Proficiency in implementing change control principles - Excellent verbal and written communication skills - Experience working in clean rooms (desirable),