Quality Control Biotechnician (Hay Level 12/C1) – 2 Posts
Reference Number: QCTECHNICIAN02
Department: NTPQMQB11111111 – Quality Control
Location: Pretoria
Closing Date: 28 January 2025
Job Purpose
The Quality Control Biotechnician will perform sterility and endotoxin testing of raw materials, in-process samples, and finished products at NTP. The role includes water testing of facilities and assisting with environmental monitoring in classified areas.
Key Performance Areas
Microbiological Analyses
- Advanced knowledge of pharmaceutical microbiology and related guidelines.
- Familiarity with pharmacopeial standards and sterile product testing.
- Expertise in environmental monitoring and qualification of clean rooms under cGMP standards.
- Solid understanding of microbiology instruments and calibration requirements.
- Proficient in cGMP and GLP compliance.
Laboratory Consumables and Equipment Management
- Operate and maintain microbiology equipment per SOPs, ensuring cleanliness, validation, and calibration.
- Perform equipment calibration checks and coordinate necessary maintenance.
- Ensure availability of reagents, supplies, and materials for testing.
Management of Laboratory Consumables
- Maintain adequate stock of consumables for microbiological analyses.
- Conduct quality checks on consumables.
- Operate water testing systems, pH/conductivity meters, TOC analyzers, and general lab equipment.
- Perform routine analysis on raw materials, in-process, and final products.
- Support out-of-specification (OOS) investigations.
Reporting and Record-Keeping
- Ensure compliance with regulatory requirements for microbiological analyses in classified production areas.
- Document and store data following SOPs and regulations.
- Accurately report results, including OOS findings and deviations.
- Participate in investigations and corrective/preventive action plans.
- Fully utilize the LIMS system for data management and reporting.
Technical and Team Support
- Work effectively in a fast-paced, diverse environment.
- Assist with microbiological media preparation, sample labeling, and environmental monitoring.
- Provide professional communication and knowledge sharing internally and externally.
- Ensure SHEQ records are updated and safety measures are followed.
Knowledge and Skills
- Proficient in microbiological testing methods and compliance standards.
- Advanced technical knowledge of laboratory equipment and related processes.
- Strong time management and organizational skills.
- Understanding of pharmaceutical manufacturing and corrective action programs.
- Effective communication and report-writing skills.
- Skilled in using LIMS software.
- Capable of maintaining accuracy under pressure and meeting deadlines.
Minimum Requirements
- Education: National Diploma in Biotechnology or B.Sc. with Microbiology as a major.
- Experience:
- Minimum 2 years of laboratory experience in a pharmaceutical setting.
- Exposure to cGMP regulations.
- Other Requirements:
- Medically fit for radiation and chemical work.
- Ability to work independently with sound judgment and problem-solving skills.
- Self-motivated and eager to learn beyond production activities.
Contact Information
- Contact Person: Ms. Francisca Dos Santos
- Email: FranciscaDosSantos@ntp.co.za
Application Details
- How to Apply: Submit your application online at Necsa Online Recruitment Portal by the closing date.
Employment Equity
The Necsa Group is committed to Employment Equity. Preference will be given to African females, African males, and individuals with disabilities to meet Employment Equity targets.
Note: If no response is received within 30 days after the closing date, consider your application unsuccessful.
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