Quality Control QC Specialist

2 weeks ago

Western Cape, South Africa Specialist Search Recruitment Full-time

Introduction

A top pharmaceutical manufacturing company has an opportunity for a highly skilled and detail-oriented Quality Control (QC) Specialist to join their pharmaceutical manufacturing team.

The successful candidate will be responsible for conducting laboratory testing on raw materials, in-process samples, packaging components and finished pharmaceutical products to ensure that all products meet stringent requirements for quality, safety, purity and potency.

The QC Specialist will play a critical role in maintaining compliance with Good Manufacturing Practices (GMP) and applicable regulatory and pharmacopeial standards, supporting the safe and timely release of pharmaceutical products.

Duties & Responsibilities

Key Responsibilities

  • Perform analytical testing of raw materials, packaging components, in-process samples and finished pharmaceutical products.
  • Operate and troubleshoot sophisticated laboratory equipment, including HPLC, GC and other analytical instrumentation.
  • Conduct environmental monitoring of cleanrooms, water systems and air quality to assess microbial and particulate contamination.
  • Ensure all laboratory activities are performed in accordance with GMP, GDP and approved SOPs.
  • Accurately record, review and maintain laboratory data and test results in accordance with stringent data integrity requirements.
  • Utilise Laboratory Information Management Systems (LIMS) and other relevant laboratory systems.
  • Prepare and review Certificates of Analysis (CoAs) and technical documentation.
  • Investigate Out-of-Specification (OOS) results, deviations and laboratory incidents, including root-cause investigations and corrective actions.
  • Prepare clear and accurate technical investigation and incident reports.
  • Perform routine calibration, maintenance and troubleshooting of laboratory equipment.
  • Ensure laboratory instruments and equipment remain qualified, calibrated and fit for purpose.
  • Participate in continuous improvement initiatives within the QC laboratory.
  • Maintain a high level of compliance with applicable USP, EP and other pharmacopeial standards.

Desired Experience & Qualification

Minimum Requirements

  • Bachelor’s degree in Chemistry, Microbiology, Pharmacy, Pharmaceutical Sciences or a related Life Sciences discipline.
  • 2–5 years’ relevant laboratory experience within a regulated pharmaceutical, medical manufacturing or related environment.
  • Practical experience with analytical laboratory techniques and instrumentation.
  • Working knowledge of GMP and Good Documentation Practices (GDP).
  • Knowledge and practical understanding of relevant pharmacopeial standards, including USP and EP.
  • Experience with OOS, deviations and laboratory investigations will be advantageous.
  • Experience working with LIMS and electronic laboratory systems is preferred.

Interested?