Laboratory Manager
1 month ago
We are seeking a highly skilled and experienced Laboratory Manager to join our team at iStaff Recruitment.
Job Summary:The Laboratory Manager will be responsible for ensuring the highest standards of data integrity, regulatory compliance, and quality improvement in the laboratory. This includes managing day-to-day lab operations, overseeing the drafting and verification of reports, and maintaining a comprehensive apparatus maintenance program.
Key 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 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.
- Equipment Maintenance: Implement and maintain a comprehensive apparatus maintenance program.
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
What We Offer:
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.
How to Apply:
Please submit your CV and a cover letter outlining your experience and qualifications for this role. We look forward to hearing from you.
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