Laboratory Manager

SUMMARY:
We are seeking a highly motivated and experienced Lab Manager to oversee the day-to-day operations of a laboratory. The ideal candidate will be a strategic thinker with a strong understanding of laboratory management and a commitment to quality and efficiency.

POSITION INFO:
Minimum Requirements:

• Chemistry Degree or higher
• Experience and knowledge of cGxP according to SAHPRA Guidelines
• At least 9 years Lab experience
• At least 5 years management experience in a lab
• Experience with Chromeleon CDS chromatography software
• Experience with LIMS (Laboratory Information Management System)
• Document control experience
• Knowledge of statistics and ability to apply statistical rules/analyse to laboratory

• Regulatory Compliance: Ensure strict adherence to current Good Manufacturing Practices (cGMP) and applicable SAHPRA guidelines.
• Data Integrity: Maintain the highest standards of data integrity, ensuring compliance with ALCOA principles (Attribute, Legible, Contemporaneous, Original, and Accurate).
• Quality Improvement: Continuously identify areas for improvement in quality and regulatory compliance, implementing effective strategies to enhance accuracy, thoroughness, and efficiency across all laboratory functions.
• Supplier Management: Verify and process supplier documents and maintain an approved supplier database.
• Report Verification: Oversee the drafting, combining, and verification of reports, calculations, and raw data. Ensure the accuracy and integrity of results before signing off.
• Stability Program Management: Manage and maintain the laboratory's stability programs, ensuring compliance with regulatory requirements.
• Team Collaboration: Work closely with the QA Manager to enforce company policies, standard operating procedures, and regulatory requirements.
• People Management: Manage discipline matters and leave processes in conjunction with HR. Assist with performance management
• Subcontractor Management: Oversee sub-contracted projects and outsourced services, ensuring that contracted laboratories deliver the desired results.
• Supplier Qualification: Qualify service providers, subcontractors, and suppliers according to relevant Standard Operating Procedures .
• Supplier Sourcing: Source goods and services exclusively from approved suppliers listed in the organization's supplier database.
• Equipment Maintenance: Implement and maintain a comprehensive apparatus maintenance program
• Operational Oversight: Manage day-to-day lab operations, ensuring efficiency and compliance with established procedures.