This position is responsible to maintain a high level of quality assurance and quality control, in accordance with the Quality Management System, by performing analytical services in order to satisfy the clients needs in accordance with the requirements of the South African Health Products Regulatory Authority.
This role will be responsible for supervising the operating activities of the laboratory and prioritize workload to ensure customer service levels are met. This incumbent will also be responsible for site management of the shift team to ensure efficient and effective operations of the laboratory, as well as to meet reporting deadlines on the various types of samples / commodities submitted to the laboratory for analytical evaluation and ensuring confidentiality of results. PRINCIPLE DUTIES
- Ensure and assist in performing analytical tasks as assigned to shift team as per relevant Guidelines and Standard Operating Procedures of the laboratory.
- Performing analysis of samples as per Good Laboratory Practice, Good Manufacturing Guidelines, and applicable Standard Operating Procedures.
- Troubleshooting and analytic input into laboratory operations.
- Calibration of apparatus using applicable standards according to the calibration program in the laboratory compiled by the Laboratory Supervisor as per applicable SOPs.
- Preparing, calculating, and reporting raw analytical data according to ALCOA+ guidelines (Attributable, Legible, Contemporaneous, Original, Accurate and Complete).
- Responsible to maintain the Quality Management System in the laboratory according to Good Documentation, Manufacturing and Laboratory Practises.
- Preparation of reagents to be prepared correctly and accurately according to SOPs and applicable methods, documenting all relevant details e.g. reference method, measured pH, temperature etc.
- Ensure optimization of the laboratory equipment by keeping re-runs and additional tests to a minimum.
- Perform method verification, validation, transfer, and technical projects in collaboration with Technical Team.
- Perform cross checks of analytical results as required by the Laboratory Management.
- Perform Technical Reviews of analytic results as required by the Laboratory Management.
- Performing laboratory chores and duties as per laboratory duty list and reasonable requests by management.
- Assist in operational planning as required by Laboratory Management.
- Review and write SOPs in collaboration with the QA team.
- Training of SOPs and Laboratory techniques to other analysts.
- Maintain productivity in the laboratory in line with set lead times and key performance indicators.
- Participate in the laboratory safety procedures as required my management.
- Any other reasonable instructions given by management or the employer from time to time.
- Ensure shift handover is performed at the start and end of every shift with key issues identified and prioritised to the previous/next shift and recorded in the Shift Logbook to ensure all tasks are completed within the required deadlines.
- Review outstanding work with respect to customer deadlines and prioritise activities of shift team to meet customer expectations.
- During the shift, regularly review workload with respect to analytical test deadlines and use the information to prioritize activities of the shift team.
- Ensure smooth operation of the laboratory and achieve deadlines.
- Assist with appraising, coaching, training and development of lab analysts to ensure a competent and motivated team.
- 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.
- Minimum 6 years laboratory experience as an analyst in the Pharmaceutical Industry.
- Minimum 3 years experience in performing Method Development, Method Validation, Method Verification, and Method Transfer.
- Minimum 4 years experience in Technical Result Review.
- Strong Communication Skills (verbal and written)
- Deadline driven
- Quality Focus
- Coping with Pressures and Setbacks
- Analytical skills required
- Detail oriented
- Deciding and Initiating Action
- Leading and Supervising
- Persuading and Influencing
