Laboratory Specialist for Analytical Testing
2 weeks ago
Job Description:
A Laboratory Specialist is required to carry out tasks and projects related to equipment, lab utilities, and testing procedures as per Good Manufacturing Practice (GMP) guidelines.
This position partners with other departments to ensure that all QC testing activities are completed efficiently.
Key Responsibilities:
- Carries out analytical testing activities in relation to method validation and technical transfer activities to ensure compliance with ICH, USP, and EP guidelines.
- Executes validation, operation, maintenance, calibration, and troubleshooting of equipment and its associated software.
- Writes, executes, reports, and reviews IQ/OQ and PQ protocols to ensure qualification of relevant equipment for cGMP use.
- Performs routine and non-routine analytical testing activities.
- Reviews and approves laboratory test results.
- Ensures that testing and results approval are completed within agreed turnaround times.
- Writes and reviews laboratory TMs, SOPs, and WIs as directed by company policy.
- Maintains and develops knowledge of analytical technology as well as cGMP standards.
- Liaisons with Operations department regularly throughout the day to ensure testing activities are completed in an efficient manner and issues rectified.
Requirements:
- A third-level qualification of a scientific/technical discipline is required.
- Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
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