Laboratory Team LeaderThe Laboratory Team Leader position will be part of an effective team that interacts with multifaceted parts of the organisation, including, but not limited to Quality Control, Sample Management, Lab Compliance, and Lab Services.
This position is responsible for maintaining a high level of quality assurance and 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 supervise the operating activities of the laboratory and prioritise 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.
Duties & ResponsibilitiesEnsure and assist in performing analytical tasks as assigned to the shift team as per relevant Guidelines and Standard Operating Procedures of the laboratory.Perform analysis of samples as per Good Laboratory Practice, Good Manufacturing Guidelines, and applicable Standard Operating Procedures.Troubleshoot and provide analytic input into laboratory operations.Calibrate apparatus using applicable standards according to the calibration programme in the laboratory compiled by the Laboratory Supervisor as per applicable SOPs.Prepare, calculate, and report raw analytical data according to ALCOA+ guidelines (Attributable, Legible, Contemporaneous, Original, Accurate, and Complete).Maintain the Quality Management System in the laboratory according to Good Documentation, Manufacturing, and Laboratory Practices.Prepare reagents correctly and accurately according to SOPs and applicable methods, documenting all relevant details e.g. reference method, measured pH, temperature, etc.Ensure optimisation of laboratory equipment by keeping re-runs and additional tests to a minimum.Perform method verification, validation, transfer, and technical projects in collaboration with the Technical Team.Perform cross checks of analytical results as required by the Laboratory Management.Conduct Technical Reviews of analytic results as required by the Laboratory Management.Perform 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.Train other analysts on SOPs and Laboratory techniques.Maintain productivity in the laboratory in line with set lead times and key performance indicators.Participate in laboratory safety procedures as required by management.Follow 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 clearly 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 the shift team to meet customer expectations.Regularly review workload during the shift with respect to analytical test deadlines and use the information to prioritise 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.Desired Experience & QualificationKNOWLEDGE 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 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.
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