Computer Systems Validation

- Responsible for the overall management of the department and all major decisions regarding the selection, maintenance and repair of equipment and systems in the facility. - Establishes the strategies for the medical devices manufacturing plant to achieve desired efficiency levels from equipment and systems and drives cross-functional collaborations and continuous improvements efforts. - Accountable for meeting the department's operational and financial targets. - Champions innovation of equipment and systems within the facility and drives new applications of analytics, technology and automation to enhance the maintenance and management of equipment, systems and energy resources. - Retains accountability for risks and regulatory compliance for the department and approves contingency plans in the event of disruptions and emergencies. - Inspiring and influential leader, highly skilled in developing capabilities, building strong teams and engaging internal and external stakeholders to drive organisational success. - Have a passion for driving a culture of innovation within and beyond the department to enhance the overall reliability and efficiency of medical devices manufacturing operations.

- Applies engineering principles and techniques to optimise the equipment and systems within the manufacturing facility. - Provides technical guidance and direction for the installation of equipment and systems. - He develops plans for the maintenance of equipment and systems, and recommends engineering solutions to troubleshoot faults. - Innovates equipment and systems, and contributes to manufacturing equipment and systems improvement projects by conducting feasibility assessments and tests on TC SMR technologies. - Manage energy resources and utilities by developing solutions to optimise machine availability and energy efficiency. - Ensure compliance with Standard Operating Procedures (SOPs), Health, Safety and Environment (HSE) regulations and Current Good Manufacturing Practices (CGMPs) within his purview. - Develops guidelines and conducts equipment qualification and validation in line with biopharmaceuticals manufacturing regulatory requirements. - Possess an enquiring and analytical mind and have a knack for investigating issues, analysing multifaceted engineering problems and developing solutions. - A strong team player who can guide and mentor others, and communicate technical advices and solutions to colleagues beyond the team.

The Engineering and Maintenance Principal/Senior Engineer applies advanced engineering principles and techniques to troubleshoot complex engineering problems encountered within the manufacturing facility and provides expert technical advice to guide the installation and maintenance of equipment and systems. He/She is expected to lead the technical cross-collaboration with the Process Development/Manufacturing Science and Technology (PD/MSAT) department in order to identify appropriate biopharmaceuticals manufacturing equipment and optimise their functionalities. The Engineering and Maintenance Principal/Senior Engineer leads manufacturing equipment and systems innovation projects by guiding feasibility assessments and tests on TC SMR technologies. He is expected to review and approve solutions and initiatives to optimise machine availability while managing energy and utility use. He sets parameters for equipment qualification and validation in line with biopharmaceuticals manufacturing regulatory requirements. The Principal/Engineer must ensure compliance with Standard Operating Procedures (SOPs), Health, Safety and Environment (HSE) regulations and Current Good Manufacturing Practices (CGMPs) within his purview. The Engineering and Maintenance Principal/Engineer carries the responsibility of the in-house technical expert. He should possess a deep passion for analysing and resolving multifaceted engineering problems and be able to apply advanced critical and analytical thinking skills to deal with immediate situations. He should have a developmental and amiable approach in his interactions working as part of a team while guiding and mentoring others. He must also be able to communicate engineering concepts in a manner that will be understood by others within and beyond the team.

The Quality Assurance Manager approves TC SMR or improved processes and systems to ensure that quality standards in biopharmaceuticals manufacturing plants are upheld. He/She holds overall responsibility for the Quality Assurance departments activities within the organisation. He is responsible for all major decisions regarding the validation of manufacturing processes, product registration, release and recall, as well as internal and external audit policies. The Quality Assurance establishes strategies for biopharmaceuticals manufacturing plants to achieve desired quality levels based on industry best-practices and regulatory requirements. He drives cross-functional collaboration and continuous improvements efforts. In addition, the role is accountable for the QA departments meeting their operational and financial targets. The QA Manager possesses excellent leadership skills and is able develop capabilities, build strong teams and engage internal and external stakeholders. He is adept at inspiring and driving a culture of innovation and continuous improvement within and beyond the department to enhance the overall quality of the organisations products. He possesses the competitive drive to bring the organisation's quality standards to global recognition.

- Implements validation processes to identify deviations and potential risks in the manufacturing processes. - Responsible for first-line verification of quality standards in the organisation and supports the product release and registration process by collaborating with other departments to gather relevant information. - Assists in audits, handles quality queries, delivers quality-related training, and is responsible for ensuring that documents are organised and managed according to standard procedures and requirements. - Communicates with customers on product enquiries and develops practical solutions to implement workflow improvements and enhance department operations. - Meticulous and systematic in carrying out his tasks, and exercises critical and analytical thinking to identify discrepancies in processes and resolve problems. - Applies communication and teamwork skills to interact effectively with others to achieve organisational objectives.

QC manager ensured that products meet the required quality standards and regulatory requirements. The QC Manager oversees the quality control processes throughout the production lifecycle to ensure that pharmaceuticals are safe, effective, and of high quality. Establish and maintain quality control policies and procedures in alignment with regulatory requirements, industry standards, and company objectives. Ensure the QC department has the necessary resources, including equipment, reagents, and personnel, to perform quality control tests effectively. The QC Manager possesses excellent leadership skills and is able develop capabilities, build strong teams and engage internal and external stakeholders. He is adept at inspiring and driving a culture of innovation and continuous improvement within and beyond the department to enhance the overall quality of the organisations products. He possesses the competitive drive to bring the organisation's quality standards to global recognition.