QC Analayst
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Job Location:
Durban - South Africa
Monthly Salary:
Not Disclosed
Posted on:
20 hours ago
Vacancies:
1 Vacancy
Job Summary
Our client in the pharmaceutical industry is looking for QC lab analyst to start asap for a 3 months fixed contract based KZN. If you meet the below requirements please send us your CV.
The QC Lab Analyst is responsible for performing analytical testing of raw materials in-process samples finished products stability samples and water systems in accordance with approved specifications GMP requirements and standard operating procedures (SOPs). The role supports product quality regulatory compliance and continuous improvement within the laboratory environment.
Requirements:
The QC Lab Analyst is responsible for performing analytical testing of raw materials in-process samples finished products stability samples and water systems in accordance with approved specifications GMP requirements and standard operating procedures (SOPs). The role supports product quality regulatory compliance and continuous improvement within the laboratory environment.
Requirements:
- Test raw materials packaging materials finished products and stability samples according to approved methods.
- Prepare reagents standards volumetric solutions and mobile phases.
- Operate calibrate troubleshoot and maintain laboratory instruments.
- Review analytical data for accuracy and completeness before submission.
- Record and maintain laboratory documentation in compliance with GMP and data integrity requirements.
- Investigate out-of-specification (OOS) out-of-trend (OOT) and laboratory deviations.
- Participate in method validation method verification and method transfer activities.
- Ensure compliance with:
- GMP
- GLP
- SOPs
- Pharmacopoeial requirements (USP BP EP)
- Support internal and external audits and regulatory inspections.
- Maintain laboratory cleanliness and safety standards.
- Assist with stability studies and environmental monitoring where required
- Bachelors Degree or National Diploma in:
- Chemistry
- Analytical Chemistry
- Biochemistry
- Pharmaceutical Sciences
- Microbiology (if applicable)
Experience
- 23 years experience in a pharmaceutical QC laboratory.
- Experience working in a GMP-regulated environment.
- Hands-on experience with HPLC is typically essential.
Technical Skills
- Strong understanding of pharmaceutical analytical techniques.
- Knowledge of GMP GLP and data integrity principles.
- Familiarity with pharmacopoeias (USP/BP/EP).
- Experience with laboratory software systems (e.g. LIMS Empower Chromeleon).
- Ability to interpret analytical results and trends.
Soft Skills
- Strong attention to detail.
- Good documentation practices.
- Problem-solving and investigation skills.
- Ability to work independently and within a team.
- Good communication and time-management skills.
Preferred Qualifications (Advantageous)
- Experience in sterile manufacturing or API manufacturing.
- Exposure to stability programs and validation activities.
- SAP or LIMS experience.
- Knowledge of regulatory requirements from:
- SAHPRA
- FDA
- MHRA
- WHO
