WHAT YOU WILL DO
Description
- The Lab Analyst will mainly support testing/ monitoring functions pertaining to aseptic manufacturing and microbiological testing of Raw materials, Excipient, In-process materials, semi finished and finished products manufactured in the plant facilities.
Main Responsibilities:
- Perform sampling/testing as per Standard Operating Procedures including relevant documentation work required for the inspection and the sampling such as sample label generation to perform SAP transaction
- Perform routine/non-routine quality monitoring, sampling and testing of Utility systems inclusive of Purified water, Water for Injection, Pure Steam, Compressed Air and Nitrogen systems.
- Perform the routine/ non-routine environmental monitoring for all required plants, facilities, cleanrooms, hygienic areas and labs, inclusive of particle monitoring test.
- Perform personnel qualification/re-qualification, and qualification/re-qualification of the cleanrooms
- Perform routine and Batch related Environmental monitoring in cleanrooms and other production areas and laboratory.
- Provide testing support to plant validation activities
- Perform filing and archival of Microbiology lab GMP documents such as laboratory datasheet and logbooks.
- Support document uploading and tracking through the use of appropriate metrics and tools.
- Ensure that tasks as assigned are performed in a timely manner in accordance with standard operating procedures (SOPs) and current GMPs and GLP with necessary safety precaution.
- Carry out equipment cleaning and facility cleaning activities.
- Documentation support to the department by participating in miscellaneous work assigned by the Senior, Lead Microbiologist, Manager.
- Assist in maintaining good housekeeping of the work areas.
- Conducts work in accordance with Company EHS procedures, guidelines and expectations and demonstrate best EHS practice.
- Maintains positive working relationships among employees and fosters an environment where employee engagement, empowerment, teamwork and accountability are the cultural norm
- Any other duties as assigned by the Supervisor / Manager.
WHAT YOU MUST HAVE
Qualifications
- Diploma Microbiology / Biotechnology / Life Sciences or equivalent
- At least 2 years of experience in a GMP environment
Required Skills / Experience / Competencies:
- Good understanding of Safety and cGMP practices
- Computer Literacy
- Good oral and written communication skills
- Ability to work independently with excellent organizational skills, attention to detail, and follow-through.
Job requirements
- Based on site
WHAT YOU CAN EXPECT
- Limitless opportunities across various areas in Manufacturing; well-structured career path
- A state-of-the-art facility that delivers solution to its customers world-wide
