Job Description

Quality Control Manager - PinetownFull job descriptionJob Advert SummaryGuided by its purpose to provide products for patients to alleviate pain and suffering and improve their quality of life, NBIs 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 Manager: Quality Control. The successful incumbent will be required to:Contribute to the quality, safety, and efficacy of NBIs products through rigorous quality control processes, adhering to sound scientific principles and complying with current good manufacturing practice (cGMP). Further, the QC manager is responsible for the smooth, efficient day to day operation of the QC laboratory, providing operational assurance in support of business and strategic requirements.Applications are invited from suitably qualified and experienced candidates.Minimum RequirementsMasters degree in chemistry, analytical chemistry, biochemistry or other relevant degreePhD in Chemistry preferredComputer literacy: MS Office, SAP, LIMSAt least 5 years laboratory experienceAt least 3 years QC lab management experience in a pharmaceutical or similar environmentComplete understanding of cGMP, GLP and international pharmaceutical standardsHands on experience with internal and vendor audits will be an advantageDuties and ResponsibilitiesQC department / laboratory managementPlan and coordinate sample testing based on product specifications and production needs.Manage QC lab staff for timely analysis and reporting of raw materials and products.Report results in various formats, including certificates of analysis (CoAs).Ensure prompt release of raw materials and intermediate products for production.Develop and enhance internal quality control systems in line with GMP and industry standards.Implement and maintain an external proficiency testing program.Establish quality requirements and maintain in-house controls and reference standards.Review and approve QC activities and procedures for quality and compliance.Stay updated on cGMP requirements and regulatory expectations.Regularly review QC procedures to ensure best practices.Ensure adherence to scientific principles and proper statistical methods in QC analysis.Specifications for all materialsApprove, develop and maintain specifications for all materials used in pharmaceutical and diagnostic product production.SAP and LIMSEnsure all SAP and LIMS transactions are completed as required for the release of raw materials, intermediates and final products.Perform SAP tasks as required by the quality management system and other business processes.Ensure LIMS and SAP is optimally set up and utilised to support effective, productive and efficient QC laboratory operations, and identify opportunities for further improvement to maximise LIMS functionality.Analytical methods and QC equipmentAssess the feasibility and benefits of new analytical methods, preparing justifications and CAPEX requests.Develop user requirement specifications for new QC facilities, equipment, and contract testing.Assist the Validation Team in preparing IQ, OQ, and PQ documents for qualification.Coordinate equipment qualifications and method validations, providing necessary documents to Regulatory Affairs for SAHPRA submissions.Oversee the implementation of new analytical methods and QC equipment post-SAHPRA approval, following NBIs change management procedures.Maintain a program for calibrating, servicing, and maintaining analytical equipment to ensure accuracy and prevent breakdowns.Management of external / contract laboratoriesIdentify and assess external laboratories for analytical testing as backup to in-house QC.Ensure contract laboratories use suitable and validated analytical methods.Audit contract laboratories per as NBIs vendor management program.Review external testing service agreementsCompany strategyContribute to company strategic plans and their implementation.Participate in strategic initiatives and continuity in leadership.Ensure alignment of the QC department with company-wide strategic initiatives.Review and reporting of trendsMonitor, analyse and report on trends of key QC performance indicators as part of monthly, quarterly and annual reviews and reports, including annual product quality reviews, or APQRs.Coordinate with applicable QC staff to ensure the monthly review of reference standards and inhouse controls is performed, including statistical analysis and reporting of the trends.Ensure the appropriate use of sound statistical analysis of QC results.Prepare quarterly and annual reports on analytical results of raw materials, in-process and final product testing, as well as utilities.Attend quarterly and annual review meetings and provide input into the meetings as required.Coordinate with the Lead QC Analyst to ensure that stability reports are prepared, reviewed and shared with stakeholders.Health, safety and the environmentEnsure compliance to all relevant legislation e.g. Occupational Health and Safety Act.Coordinate the investigation of SHE incidents in the department, and identify and implement effective CAPAs to prevent recurrence.Ensure that NBIs procedure on waste management is being followed in the laboratory.Support for other NBI departmentsStay updated on advancements in analytical techniques for biopharmaceuticals to support interdepartmental discussions.Contribute to cross-departmental projects and troubleshooting with QC support and technical advice.Evaluate new raw materials, excipients, printed packaging materials, and closure systems for production support.Provide analytical support for new product developmentMaintain the quality system to ensure GMP complianceEnsure compliance to NBIs quality management system, GMP principles and SAHPRA guidelines in the QC department.Establish, review, and enforce SOPs for processes and analytical methods.Communicate QMS requirements to staff.Prepare for and participate in GMP audits by third parties and regulatory authorities.Conduct internal audits and implement corrective actions for continual improvement.Coordinate with QC staff to identify, document and implement CAPAs for non-conformances from audits and inspections.Collaborate with Quality Division managers to foster a culture of quality and uphold the NBI Quality Policy.Identify and implement continuous improvement initiatives, including annual Quality Objectives for the QC department and monitor progress.Coordinate out-of-specification root cause investigations per NBIs SOP and distribute reports to stakeholders.Coordinate customer complaint investigations, and prepare reports in compliance with NBIs SOP.

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