Job Description
- Perform quality control microbiological testing of raw materials, intermediates, and finished products to ensure compliance with specifications and standards.
- Ensure timely testing of production environmental monitoring and production water quality.
- Perform microbiology testing data trending and escalate any adverse trends accordingly.
- Conduct investigation on out of specifications, deviation from regular and/or any other Non-Conformance Investigation related to microbiology and carry out literature research when required.
- Support equipment qualification, perform and coordinate calibration, and maintenance of microbiology laboratory equipment.
- Proactively support in continuous improvements of microbiology functions and participating in writing/revising SOPs and protocols.
- Manage the overall status of sample lab and R&D samples by performing sensory, physical and analytical testing procedures with creation of specification.
- Oversee and maintenance of Retained Sample Management.
- Ensure proper functioning and running of QC laboratories (Chemical, sensory, microbiology, retain sample room) in accordance with ISO9001, 5S, lean principle, ISO14000 and OSHAS 18001 standards and procedures.
Qualifications
- Minimum Diploma or Degree in Microbiology, Biology or equivalent in years of similar experience
- Overall work experience of at least 5 years in a similar position.
- Proficient in methods and practices of microbiological techniques and environmental monitoring
- Knowledge in standards and global regulatory requirements applicable to microbiology and environmental monitoring in biologics.
- Effective interpersonal attributes at all internal and external levels.
- Good time management and project management skills