Quality Control Manager at National Bioproducts Institute

Minimum Requirements

• Masters degree in chemistry, analytical chemistry, biochemistry or other relevant degree
• PhD in Chemistry preferred
• Computer literacy: MS Office, SAP, LIMS
• At least 5 years laboratory experience
• At least 3 years QC lab management experience in a pharmaceutical or similar environment
• Complete understanding of cGMP, GLP and international pharmaceutical standards
• Hands on experience with internal and vendor audits will be an advantage

Duties & Responsibilities

QC department / laboratory management

• Plan 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 materials

• Approve, develop and maintain specifications for all materials used in pharmaceutical and diagnostic product production.

SAP and LIMS

• Ensure 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 equipment

• Assess 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 NBI’s change management procedures.
• Maintain a program for calibrating, servicing, and maintaining analytical equipment to ensure accuracy and prevent breakdowns.

Management of external / contract laboratories

• Identify 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 NBI’s vendor management program.
• Review external testing service agreements

Company strategy

• Contribute 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 trends

• Monitor, 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 environment

• Ensure 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 CAPA’s to prevent recurrence.
• Ensure that NBI’s procedure on waste management is being followed in the laboratory.

Support for other NBI departments

• Stay 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 development

Maintain the quality system to ensure GMP compliance

• Ensure compliance to NBI’s 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 NBI’s SOP and distribute reports to stakeholders.
• Coordinate customer complaint investigations, and prepare reports in compliance with NBI’s SOP.