Analytical tasks as assigned by laboratory management in terms of GLP aligned with a pharmaceutical analytical culture. Tasks should be performed by the currently 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 program in the laboratory compiled by the Laboratory Supervisor as per applicable SOPs.
Shift Lab Analysts must verify the 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 the Responsible Person / General Manager, Contemporaneously.
Responsible for maintaining the Quality Management System in the laboratory according to Good Documentation, Manufacturing, and Laboratory practices.
Preparation of reagents is 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 utilization 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 the 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 my management.
Ensure that all laboratory work areas and workstations are kept clean and tidy (Good Housekeeping).
Ensure that the Companys Health and Safety policy is applied effectively.
Any other reasonable instructions given by management or the employer from time to time.
KNOWLEDGE REQUIRED
Computer Literate with analytic software.
Minimum Qualification required: Relevant Diploma or Degree in Analytic 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.