Job Description
Responsibilities
- Lead or participate in investigation arising from laboratory investigation, incidents and accurately assess the impact of the failure to make appropriate recommendations remedial actions for follow-up.
- 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 testing technologies and methods.
- Involve in the approving 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. Upon completion, review and ensure closure of changes.
- Draft, compile, review and update appropriate laboratory documents such as testing protocol, procedures and guidelines...