About the Company:
Our client is one of the leading pharmaceutical ophthalmic solutions manufacturers in the world, dedicated in providing sterile pharmaceutical ophthalmologic solutions, from prevention to delivery of care at every touchpoint, advancing wellness in hospitals, clinics and home-care sectors.
Position Overview:
The incumbent provides supervisory and testing support to the QC Microbiology laboratory in sterility testing, environmental testing, bioburden testing, validation activities, and ensure SOPs complies with applicable ISO standards, regulatory requirements and compendial testing methods.
Responsibilities:
- Perform and supervise all microbiological testing as required such as sterility test, total microbial count, particulate count, growth promotion test, gram stains, endotoxin test, environmental monitoring, etc.
- Provide guidance and coach lab technicians on microbiological testing and environmental monitoring.
- Ensure all microbiological lab resources are utilized productively with lab goals and priorities.
- Supervise the environmental monitoring program and ensure effectiveness.
- Promote awareness with impacted departments on the control of the sterility assurance of the products and manufacturing processes.
- Work with various departments on the expectation of the sterility assurance requirements of sterile product and prevent product contamination.
- Continuously improve the lab practices by updating procedure and conducting training.
- Support audits, validations, change control, product registration and preparation of relevant reports.
- Conduct lab investigations and implement appropriate corrective/preventive actions.
Requirements:
- Diploma/Degree in Life Science (Microbiology, Biology, Biotechnology, Pharmaceutical).
- Scientifically, materials, products and process evaluation or validation required by rules and regulations with relevant education and experience.
- In-depth knowledge of the cGMP, 21 CFR Part 211, EU MDD/MDR and ISO 13485.
How to Apply:
Interested candidates, please submit your updated resume by using Apply Now button
*We regret to inform that only shortlisted candidates will be informed.*
Sarah Sevilla
Registration Number: R22107553
EA License No: 18C9027
