Job Description

Senior Validation Officer - PinetownJob Advert SummaryTo support NBIxe2x80x99s mission, vision, core values and quality management system through the maintenance of a validation program, ensuring the principles of cGMP are practiced and the relevant product lines, equipment and facilities are maintained in a qualified state.To ensure compliance with the NBI Validation Master Plan and cGMP requirements of all validation associated activities executed at NBI. This includes the drafting of required validation protocols, execution of validation activities and compilation of validation reports. In addition, to conduct training where required.Oversee Validation Officers and Validation Interns day-to-day tasks ensuring all validation requirements are timeously met.Minimum RequirementsBachelorxe2x80x99s Degree or National Diploma in Chemical engineering, Biotechnology, Chemistry, or related Science or Engineering field.At least 5 yearsxe2x80x99 experience in a pharmaceutical manufacturing environment with working knowledge of pharmaceutical facilities, equipment, laboratories, utilities and systems is required.A minimum of 3 yearsxe2x80x99 specifically in validation of equipment, manufacturing processes and analytical methods, and utilitiesA minimum of 2 yearsxe2x80x99 experience in a supervisory role, supervising staff within a team.Specific Operational RequirementsThe successful candidate will be required to work an 8-hour shift as rostered.May be required to work overtime to meet the business needs.Must be prepared to work shifts/weekends/public holidays when needed.Specific SHE RequirementsPre-employment, routine, and exit medicals are compulsory due to the nature of the business.Attendance to SHE-related training is mandatory.Adherence to SHE Instructions (Waste Segregation, Water and Energy Saving Initiatives)Compliance with SHE Site Rules is compulsory.NBI uses hazardous and biologically active chemicals. The successful candidate will be required to use proper PPE and will go through medical examinations as per OSH Act requirements.Duties and ResponsibilitiesValidation Planning and ExecutionActively involved in the execution of qualification and re-qualification projects affecting all aspects of pharmaceutical validation, namely equipment, facility, utility qualification/s, computer system and cleaning validation, etc.Monitor project progress against the Validation Master Plan and report on progress to the Validation Manager.Ensure compliance of the validation processes and procedures followed with all aspects of cGMP, GLP & GAMP, and Good Validation Practice. Aspects must be reflected in Validation protocol, methodology, procedures and reports.Plan, co-ordinate and oversee routine and non-routine activities of the Validation Officers/Interns day-to-day tasks.Assist the Validation Manager with planning of the Validation Master Plan execution, timeline and resource allocation.Conduct meetings liaising with the validation team on their project focus.Assist with validation master plan updating.Witness or delegate witnessing of all validation/calibration services conducted by a third party contractors or service providers.Provide detailed and accurate feedback to the Validation Manager and other departments in NBI, to highlight areas where continuous improvement in the quality departmental activities are required.Ensure that all validation activities are executed in a timely manner following the approved protocols and any discrepancies are noted, investigated and closed off.Manage all re-validation activities within NBI.Provide feedback and liaise with external service providers to ensure compliance with NBI requirements of validation activities.Validation DocumentationManage the drafting of validation protocols and their status on the document management system.Compile validation protocols based on the requirements of the user, taking into account cGMP and other relevant guidelines.Initiate and drive compilation of validation protocols of major projects.Amend and address commentary on the validation protocols prior to implementation.Execute all aspects of quality documentation associated with validation in conjunction with the Validation Manager and Validation Officers.Prepare and implement a robust system for filing and retrieving of reports, certificates and related validation documentation in conjunction with the Validation Manager.Ensure that the Validation Master Library is reflecting the system for filing and retrieving of validation related documents and certificates.Keep the Validation Master Library up to date and filing in an appropriate and approved locations. Communicate library allocation to the Validation Manager and Validation Officers where necessary.Validation ReportingManage timely completion of Validation reports generated by the Validation team.Independently review analytical data and conduct statistical analysis for validation reports.Compile process validation studies/protocols.Collate and review the validation data obtained and compile validation reports for each validation activity conducted.Review and amend validation reports where necessary.Effectively and timeously communicate deviations to the Validation Manager and relevant equipment/process owners.Quality SystemsInitiate and complete impact and risk assessments related to validation projects to ensure validation activities are conducted according to a risk-based approach.Implement corrective and preventive measures within the team following any non-conformances or deviation identified during validation studies.Manage delegated tasks on document management system and quality management system.Calibration and re-qualification programmeEnsure that all validation instrumentation is calibrated on time as per preventative maintenance schedule.Perform internal calibration and verification of QA validation temperature probes used for mapping and calibration studies. Conduct calibrations of specialised data loggers.Coordinate, monitor and witness calibrations and testing of validation elements.Administration of critical instrument calibration and all calibration certificates.TrainingCompile SOPxe2x80x99s where necessary and provide training of staff on relevant SOPxe2x80x99s developed during validation.Drive the compilation of Validation SOPxe2x80x99s.Validation sample managementSampling of different locations, or equipment for microbiological and chemical testing.Sampling of in-process products for validation.Logging of samples in the LIMS system.Management (including handling and storage) of samples to ensure sample integrity and that they are processed and delivered to the relevant laboratory correctly.Capturing results from the LIMS system and collating them for reports.Liaise with NBI laboratories for results and sampling plans.Ad-hoc/ otherProvide support to all the NBI departments regarding validation requirements and issues.Assist with other QA activities as and when required.Manage Validation consumables inventory.Represent the Validation Manager when delegated.CompetenciesManaging RelationshipsPersonal LeadershipBusiness ImpactLeading and Influencing OthersEffective interpersonal skills and emotional intelligenceQuality orientation and awarenessExcellent planning and organising skillsStrong analytical and problem solving skillsAbility to work independently with minimal supervisionExcellent technical writing skills is requiredAbility to handle typical team conflicts

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