Quality Control Manager 20 views
Job Overview
- Salary Offer Market Related
- Experience Level Senior
- Total Years Experience 5-10
Purpose:
A manufacturing company that specialises in pharmaceutical products made from human plasma is seeking a Quality Control Manager who will be responsible to contribute to the quality, safety, and efficacy of company 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
Key Job Outputs:
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 company 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 company 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 on 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 company procedure on waste management is being followed in the laboratory
Support for other company 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 company 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 company 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 company SOP and distribute reports to stakeholders
- Coordinate customer complaint investigations, and prepare reports in compliance with company SOP
People management
- Ensure adequate staffing of the department
- Effective management of the department/team by actively contributing to and supporting company people management agenda, including leave, overtime and resource management, management of misconduct with company HR framework, promoting employee engagement, etc.
- Setting both departmental and individual objectives in order to meet company strategic objectives, in the form of individual performance plans
- Lead, motivate and develop staff to ensure the appropriate objectives of the department are met
- Evaluate and manage employee performance by conducting performance appraisals at defined regular intervals and implement corrective or remedial actions as required
- Identify, support and implement learning and development needs for QC staff, in collaboration with People Management
- Identify all staff competency-based training requirements and provide the necessary training and/or arrange external training
- Effective recruitment and selection of new staff
- Provide developmental, coaching and job enrichment opportunities to maximise employees’ potential
- Support transformation, the execution and achievement of company EE plan, diversity and inclusion within their respective departments
General administration
- Accurate and timely compilation of all annual QC cost centre budgets, and submission of the budgets ahead of the deadlines
- Effective controlling of the expenses against budget
- Compiling monthly report for the QC cost centres and Head: QM as required
- Authorise all payments to suppliers to the department and control all departmental expenditure in accordance with budget
- Identify and motivate for capital equipment required to optimise the operations and in line with requirements of the QC department
- Assist the Head of Quality Management and Scientific Affairs as and when required
Core Competencies:
- Leading and influencing others
- Managing relationships
- Personal leadership
- Business impact
Qualifications:
- Masters degree in chemistry, analytical chemistry, biochemistry or other relevant degree
- PhD in Chemistry preferred
Experience:
- 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
- Computer literacy: MS Office suite, SAP, LIMS
Salary: Market related
Should you not hear from us within 2 weeks, kindly consider your application as unsuccessful.
All personal information received will be processed in accordance with The Protection of Personal Information Act No. 4 OF 2013