The person will be focusing to execute, and coordinate of equipment and/or facility maintenance activities and projects on-site. He/She ensures that the maintenance, calibration, qualification and validation of equipment, facilities, utilities, and processes are carried out in accordance with applicable GMP, GLP and/or ISO17025 guidelines.
JOB RESPONSIBILITIES
- Update the Master Schedule and Equipment Control Database for equipment-related activities to ensure that they are performed according to SOP.
- Coordinate and supervise periodic maintenance, performed in-house or as arranged with external vendors for repair and calibration of equipment, and critical utilities
- Manage facility maintenance activities and coordinate with external vendors for facility needs and requirements (For example, Pest Control programmes, biohazard and chemical waste management programmes, etc).
- Supervise the installation, maintenance, operation, repair and adjustments made to all equipment and Facilities e.g. (HVAC, pumps, boilers, air handling units, air compressors, etc.).
- Execute daily operational activities in Facilities and Equipment Calibration. Ensure all Contractors understand their roles and responsibilities and their tasks are performed in accordance with site procedures.
- Oversee and coordinate all external contractor services to include quotations/costs, risk assessments, method statements and work permits in advance of work being carried out.
- Perform matrices reporting such as safety incident report, submit safety matrices and monthly utilities usage for tracking and monitoring.
- Participates in periodic review, harmonization of SOP for fitness-of-use, optimization and compliance to appropriate regulations for equipment systems.
- Able to conduct basic training for various equipment systems
- Maintains proper records and documentation of activities that are compliant with good documentation practices, continuous compliance ISO/IEC 17025, cGMP, PIC/S, ISPE Guidelines, WHO Technical Reports, Company global SOPs and other data integrity principles for all activities.
- To work closely with all departments to ensure the operation of a validated environment according to existing QMS and/or other regulatory requirements.
- Performs all functions as tasked with high degree of accuracy and strict adherence to company's quality requirements.
- Reviews aspects/areas for improvement within your own duties/responsibilities and make recommendations to your line manager for your own or team improvements.
- Adheres to Company Policies and Procedures.
- Undertakes any other duty or responsibility, at the request of your manager that may be required within reason within the remit of your role.
QUALIFICATIONS:
- Minimum with a diploma in Engineering, Biomedical Sciences or any related field.
- Minimum 1 year of relevant experience working in an ISO17025 / GLP / GMP work environment is preferred.
- Understanding of IT is expected, related to installation of software, interface of hardware and software.
- Effective communication and supervisory skills
- Ability to organize and prioritize work to meet deadlines
This is a one-year contract role and subject to extension.
Reg No. R1100673
EA. 99C3289
