- Performing timely data review with a high focus on data quality to ensure accuracy, completeness, cGMP and compliance of analytical documentation to departmental procedures and standards.
- Verify calculations and documented information including, but not limited to, solution and reagent expiry, instrument calibration and logbook entries ensuring that all information is complete and accurate
- Verify that all analyses performed were as per written methodologies and/or compendial methods, and were in compliance with GMP requirements
- Perform internal audits ensuring that lab operations are carried out according to approved procedures and in accordance with GMP/cGMP requirements
- Assist laboratory with regards to Out-of-Specification investigations, exceptions, and corrective actions
- Assist the laboratory with equipment calibration and maintenance
- Assist the department with the review of change control, SOP’s, deviations and other QA related documentation
- Other duties as required
Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve
- Minimum of 1 years’ experience within a laboratory environment
- BSc Degree in Chemistry or other related discipline
- Experience in the review (or peer review) of finished product, stability and analytical method validation documentation
- Basic understanding of quality systems and cGMPs.
- Ability to work independently with minimal supervision
- Previous experience with Empower software
- Previous experience with HPLC
At Bimeda we are committed to fostering an inclusive, barrier-free and accessible environment. Part of this commitment includes arranging accommodations to ensure an equitable opportunity to participate in the recruitment and selection process. If you require an accommodation, we will work with you to meet your needs.
The job posting is available in an accessible format upon request by contacting the Human Resources Manager.