Job Summary:
In this role you will support the laboratory with the following:
- To oversee the total preventive maintenance program for all laboratory equipment.
- To support the Singapore laboratory to comply with all data integrity requirements
Essential Duties and Responsibilities:
- To participate and work with the laboratory supervisors to support the laboratory with metrology support adhering to ALCOA+ principles and all data integrity requirements.
- To oversee as administrator and maintenance of existing legacy, stand-alone computerized systems with strong focus on transitioning them to fully networked computerized systems in collaboration with D&T when required.
- To ensure the GMP status and the functionality of the laboratory equipment in accordance with the guidelines 21 CRF Part 11 on data integrity.
- To support and/or implement the computer system validations in connection with the implementation of new computer-based laboratory equipment or upgrades of existing laboratory equipment.
- To establish new work instructions and process regulations in connection with computer-aided measuring systems in the laboratory and provide training to the laboratory team.
- To support the laboratory with any equipment troubleshooting and coordinate with the equipment manufacturer/distributor for timely resolution and/or commissioning external service providers when required.
- To report all protocol non-conformances and equipment failures to the laboratory supervisor.
- To execute any other duties as assigned by the laboratory supervisor
- To support and contribute actively in Lean Sigma programs and activities towards delivery of the set target
- Be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
- Be aware of his/her special responsibility towards health and safety in accordance with the company’s safety policy at all times
- Be aware of his/her special responsibility for quality and conducts his/her activities in accordance with the Company quality policy at all times
Education and Experience:
- Bachelor’s degree or equivalent experience in Computing or Chemistry or Microbiology laboratory.
- Advanced Diploma / Diploma in Computing or Chemistry or Microbiology / Pharmaceutical Science / Life Science with minimum of five years relevant laboratory experience.
Knowledge, Skills and Abilities:
- Good communication skill; able to communicate effectively in both written and verbal manner.
- Good analytical skills
- Good teamwork player
- Demonstrate technical competence through independent & resourceful research wherever applicable (e.g. through review of pharmacopeia literature & participation in forums), and translate such competence into appropriate medium (e.g. through oral & written responses to audits & regulatory inspections) to attain compliance.
Competencies/Authorities
Physical and Travel Requirements