Department
Health & Biotech
Category
Health & Biotech
Job type
Full-Time
Experience
Not Mentioned
Description
- Draft, compile, review and update appropriate laboratory documents such as analytical methods and specifications, method validation/equivalency protocols/reports, local procedures and guidelines relating to GMP and operational framework of the laboratory
- Ensure that all data supporting the resolution of process and method issues have sufficient accuracy to allow for the correct actions to be taken to address the issue.
- Contribute to the formulation and development of the plans for the implementation of new or improved testing technologies and/or methods for products and or cleaning processes.
- Ensure a safe working environment for the laboratory through participating or issuing safety risk assessment for product specific methods, or techniques or material and performing 6S inspection.
- Lead or participate in investigation arising from laboratory investigation, incidents and accurately assess the impact of the failure so as to make appropriate recommendations remedial or CAPA actions for follow-up
- Own and support Involve in the approving initiation and progression of change that may have an impact on product quality, validation, and/or cGMP compliance. This may require assessment of testing requirement, co-ordinate testing of samples and comment on change documentation and ensure closure of change and change actions. Upon completion, review and ensure closure of changes.
Qualifications
Highest qualification: University
- Minimum 3 - 5 years’ experience in an analytical environment, preferably in the pharmaceutical or regulated industry .
- Good knowledge of GMP
- Understanding product specification and method analysis
- Knowledge of laboratory instrumentation
- Laboratory support procedures
- Regulatory requirements for method validation
- Good communication skills
- Problem solving skills
- Project management skills