Shift Laboratory Analyst
The Shift Laboratory Analyst position will be working shifts and will be responsible for conducting quality control in accordance with the Quality Management System, by performing analytical services to satisfy the client’s needs in accordance with the requirements of the South African Health Products Regulatory Authority.
This role will be responsible for carrying out analytical methods and standard operating practices and reporting the results thereof to a high degree of precision and accuracy, ensuring that an effective and high-quality analytical service is provided. To meet reporting deadlines on the various types of samples/commodities submitted to the laboratory for analytical evaluation and ensuring confidentiality of results.
Duties & Responsibilities
- Analytical tasks as assigned by laboratory management in terms of GLP aligned with a pharmaceutical analytical culture. Tasks should be performed in accordance with the current available standard operating procedures of the laboratory.
- Tasks may include but not be restricted to the following:
- Chromatographic analysis
- Dissolution testing
- IR testing
- UV testing
- Titrations
- Physical tests using appropriate apparatus
- Validation of analytical methods
- Method development and validation in collaboration with senior analysts and laboratory management
- Completing of applicable logbooks in the laboratory
- Calibration of apparatus using applicable standards according to the calibration programme in the laboratory compiled by the Laboratory Supervisor as per applicable SOPs.
- Shift Lab Analysts must verify calibration date and available standards themselves beforehand.
- All determinations must be done strictly according to applicable methods as provided. Any deviations must be authorised by the QA Manager and Responsible Person/General Manager, contemporaneously.
- Responsible to maintain the Quality Management System in the laboratory according to Good Documentation, Manufacturing and Laboratory Practices.
- Preparation of reagents are the responsibility of the analyst and must be prepared correctly and accurately according to SOPs and applicable methods, documenting all relevant details e.g. reference method, measured pH, temperature, etc.
- Optimal utilisation of all apparatus is required, and repetitions should be kept to a minimum. All non-conformities should be documented and placed in the applicable file.
- Raw data must be prepared according to ALCOA guidelines (Attributable, Legible, Contemporaneous, Original and Accurate).
- Chores and duties must be performed as per laboratory duty list and reasonable requests by management.
- Productivity must be ensured in the laboratory in line with set lead times and key performance indicators.
- Participate in the laboratory safety procedures as required by management.
- Ensure that all laboratory work areas and workstations are kept clean and tidy (Good Housekeeping).
- Ensure that the Company’s Health and Safety policy is applied effectively.
- Any other reasonable instructions given by management or the employer from time to time.
Desired Experience & Qualification
KNOWLEDGE REQUIRED
- Computer Literate with analytic software.
- Minimum Qualification required: Relevant Diploma or Degree in Analytical Chemistry or equivalent.
- Thorough knowledge of statistics and ability to apply statistical rules/analysis to laboratory decision-making processes.
EXPERIENCE REQUIRED
- Minimum 5 years laboratory experience as an analyst.
- HPLC experience.
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