Section Head: Microbiology Laboratory

Job Advert Summary

Guided by its purpose to provide products for patients to alleviate pain and suffering and improve their quality of life, NBI’s vision is to be the leading African manufacturer and supplier of quality therapeutic proteins and diagnostic products.

National Bioproducts Institute NPC has a vacancy for the role of Section Head: Microbiology Laboratory . The successful incumbent will be required to:

To ensure operational excellence and effective and efficient day-to-day Microbiological Sciences and Monocyte Activation Test (MAT) laboratory operations. Additionally, to ensure quality, safety and efficacy of products and utilities through routine and non-routine in-process, final product and environmental microbiological testing, in line with NBI’s operational objectives, cGMP and quality management system requirements. To monitor and coordinate sampling, testing, and reporting of results, coordinate and monitor method development and validation of the laboratories’ assays and lastly, maintenance and improvement of the LIMS, as applicable to the specific laboratories.

Applications are invited from suitably qualified and experienced candidates.

Application Closing Date

Daily supervision and coordination of the Microbiological Sciences and MAT laboratories

Routine Supervision of Microbiology and MAT Laboratory operations:

• Oversee Laboratory operations to ensure staff perform the required duties as per testing routine and/or non-routine tasks on a day to day basis.
• Ensure all laboratory functions are carried out within the set timelines, as per the testing program
• Ensure that the integrity of Microbiology and MAT assay results is maintained by ensuring that SOPs are followed, controls comply and making necessary interventions to improve or correct current procedures and practises following the NBI deviation process.
• Ensure effective workflow and that all resources are available and effectively utilised in the Microbiology and MAT Laboratories
• Identify and resolve problems relating to staff, processes and equipment.
• Check, review and authorise results as per internal QC program.
• Manage the routine competency testing programs and training of laboratory staff on new analytical techniques.
• Manage the laboratories’ chemical and consumables stores system, including monitoring of stock usage and wastage to enhance cost effectiveness.
• Ensure that staff comply with GMP and SHE requirements on a routine basis
• Perform any required administrative tasks in keeping with the smooth running of the Microbiology and MAT Laboratories.

Technical aspects of testing of starting, Intermediate and final products and other samples

• Plan, organise and coordinate testing of incoming samples in accordance with the appropriate procedures/practises, product specification, production requirements and dossier requirements.
• Ensure that the receipt and storage of samples/reagents are performed in the appropriate containers and stored in the correct locations/conditions.
• Track and monitor the progress of testing and reporting of results to ensure test results are available within set timelines.
• Ensure that analytical tests are performed according to the approved SOP’s.
• Monitor test performance by performing statistical analysis on monthly reports on results, inhouse controls and reference standards, to identify trends.
• Provide reports on test result trends using LIMS, on monthly and quarterly basis.
• Be multi-skilled in all aspects of laboratory testing.
• Provide technical expertise to internal customers.
• Support the QC Specialist in out-of-spec investigations and handling of product quality related complaints.
• Ensure that the preparations of reagents/media according to correct recipes/procedures are performed
• Ensure results are correctly recorded by performing occasional audits of the records
• Ensure validity of test results by checking internal controls.
• Ensure adequate communication with other stakeholders
• Compile and submit analytical test reports timeously.
• Give informed opinion and analysis on results and observations when required.

LIMS/SAP QM administration

• Process and authorise results in LIMS and/or SAP
• Identify and perform LIMS improvements as required.
• Resolve operational problems that are reported.
• Implement authorised changes in LIMS and SAP QM.

Validation

• Perform test and method validations and equipment qualifications according to NBI’s Validation programme for the Microbiology and MAT Laboratories.
• Draw up qualification and validation protocols in conjunction with the QC manager and QC Specialist, as required.
• Perform validations and prepare the validation report/s, as required.
• Develop/optimise procedures and analytical methods in conjunction with the QC manager and QC Specialist,
• Implement changes, by following NBI’s change management procedure, performing risk assessments etc.

Laboratory maintenance

• Ensure sufficient stock of materials/reagents are procured to perform required duties
• Coordinate routine general laboratory maintenance to ensure the Microbiology and MAT Laboratories are clean and tidy at all times.
• Ensure water baths, incubators, fridges, cold rooms, surrounding Microbiology and MAT rooms and clean rooms are routinely cleaned following the formal cleaning program
• Ensure that the temperature, humidity and pressure in the Microbiology and MAT Laboratory rooms are maintained within specifications using the Beyond Wireless system.
• Ensure equipment is calibrated, services and maintained by liaising with Engineering Services and external service providers.

Quality Management including continuous improvement

• Ensure compliance to GMP and good laboratory techniques at all times, by instilling a culture of compliance amongst laboratory staff.
• Ensure that all reports and other related documents are completed and filed in line with cGMP requirements and NBI’s Policy on Written Records.
• Review Microbiology and MAT standard operating procedures and update the documents regularly on SAP
• Assist the QC Manager with compiling procedures for new methods/instrumentation, as required
• Liaise with QA to ensure that the folder with SOPs are kept up to date.
• Perform internal audits of QC department’s functions, assays and records to verify compliance to GMP and NBI’s quality management system.
• Conduct and guide investigations related to Microbiological and MAT out of specification results related to the laboratories
• Timeously evaluate results from the investigation and compile formal, scientifically sound reports for further evaluation by stakeholders such as QA.
• Provide effective feedback on investigation progress.
• Address non-compliance through review of root cause, and identification and implementation of effective CAPAs within agreed timeframes.
• Monitor compliance to laboratory health and safety policies and procedures.
• Identify and action opportunities for improvement to the laboratory operations and compliance.

Training and staff competency

• Ensure that all Microbiology and MAT laboratory Analysts are trained and are competent for the duties they are responsible for.
• Ensure that records for training are kept up to date.
• To prepare and execute competency tests for all Microbiology and MAT laboratory Analysts.

People Management

• Coordinate and monitor daily team operations and work assignments.
• Contribute to staff rostering and operational coverage
• Escalate complex operational and people management matters to management
• Monitor team and individual performance and provide constructive feedback
• Support staff development through coaching, training and identification as well as onboarding
• Manage basic HR processes including attendance, leave and disciplinary matters as instructed
• Support implementation and adherence of NBI policies and procedures, e.g. SHE, GMP, HR

• Bachelor’s science degree in Microbiology, Biochemistry or related field
• M.Sc. or PhD would be an advantage
• 5 years analytical or microbiology laboratory experience of which 2 years laboratory supervisory experience
• Computer literacy MS Office (Word, Excel, Power Point and Outlook)
• Experience of using software such as Laboratory Information Management System (LIMS), SAP and Minitab is an added advantage
• Understanding of GLP / cGMP.