Minimum Requirements:Chemistry Degree or higherExperience and knowledge of cGxP according to SAHPRA GuidelinesAt least 9 years Lab experienceAt least 5 years management experience in a labExperience with Chromeleon CDS chromatography softwareExperience with LIMS (Laboratory Information Management System)Document control experienceKnowledge of statistics and ability to apply statistical rules/analyse to laboratory Duties and Responsibilities: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 managementSubcontractor 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 programOperational Oversight: Manage day-to-day lab operations, ensuring efficiency and compliance with established procedures. PLEASE NOTE: Thank you for your interest in this position, we will review and be in touch if you are suitable. Due to the amount of applications we receive for each position, we are unable to respond to each one individually. Please accept your application as unsuccessful if you had no feedback within 7 days of applying. Your CV will remain on our database and we will be in touch for other suitable positions. *** In the meantime, please download our
