Lead Pharmaceutical Quality Control Analyst

Placements24

Randburg

Hybrid

ZAR 900,000 - 1,300,000

Full time

3 days ago
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Benefits offered by this job

Medical aid
Provident fund
Bonuses
Career development

Job summary

Placements24 seeks a Lead Pharmaceutical Quality Control Analyst in Randburg, Gauteng. You will lead a QC team performing testing of raw materials, in-process samples and finished products to ensure regulatory compliance and product safety.

The role requires an advanced degree in chemistry or pharmaceutical sciences and at least 7 years in QC, including 2 years in leadership. Strong methods like HPLC/GC-MS and LIMS experience are essential.

Qualifications

  • Master's or Ph.D. in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or related discipline.
  • Minimum of 7 years in pharmaceutical quality control.
  • At least 2 years in a supervisory or lead role.

Responsibilities

  • Lead, mentor, and manage a team of QC Analysts, overseeing daily laboratory operations.
  • Develop, validate, and implement analytical methods for raw materials, intermediates, and finished products using HPLC, GC, spectroscopy, and titration.
  • Perform complex analytical testing and interpret results per pharmacopoeial standards (USP, EP) and internal specs.
  • Review and approve analytical data, notebooks, and reports.
  • Investigate OOS/OOT results and implement CAPAs.
  • Ensure calibration, maintenance, and qualification of lab equipment per procedures.
  • Maintain GMP/GLP compliance and SAHPRA regulatory requirements.
  • Collaborate with R&D, Production, and QA to resolve quality issues and drive improvements.
  • Contribute to audits and stay updated on regulatory changes.

Skills

Leadership
Analytical skills
Problem solving
Decision making
Communication
Team management

Education

Advanced degree in Chemistry/Pharmaceutical Sciences

Tools

HPLC
GC-MS
UV-Vis
FTIR
Dissolution testing
Karl Fischer titration
LIMS

Job description

About the Role

Our client, a prominent player in the pharmaceutical manufacturing space, is seeking a highly skilled and experienced Lead Pharmaceutical Quality Control Analyst to join their expanding operations in Randburg, Gauteng. This pivotal role involves leading a team of QC analysts in performing critical testing and analysis of raw materials, in-process samples, and finished pharmaceutical products. The successful candidate will be responsible for ensuring that all manufactured products meet stringent quality standards and regulatory compliance requirements. This is a fantastic opportunity to take on a leadership role within a company that prioritizes scientific excellence and product safety, contributing directly to the availability of safe and effective medicines. You will be instrumental in maintaining the integrity of our client's quality systems and driving continuous improvement initiatives within the QC laboratory. The position demands a meticulous approach to analytical procedures and a strong understanding of pharmaceutical quality assurance frameworks. We are looking for an individual with proven leadership capabilities and a passion for quality in pharmaceuticals.

Key Responsibilities
  • Lead, mentor, and manage a team of Quality Control Analysts, overseeing daily laboratory operations and workload distribution.
  • Develop, validate, and implement analytical methods for raw materials, intermediates, and finished drug products using techniques such as HPLC, GC, spectroscopy, and titration.
  • Perform complex analytical testing and interpret results, ensuring compliance with pharmacopoeial standards (e.g., USP, EP) and internal specifications.
  • Review and approve analytical data, laboratory notebooks, and reports generated by the QC team.
  • Investigate out-of-specification (OOS) and out-of-trend (OOT) results, implementing corrective and preventive actions (CAPAs).
  • Ensure that all laboratory equipment is calibrated, maintained, and qualified according to established procedures and regulatory guidelines.
  • Maintain compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and relevant regulatory requirements (e.g., SAHPRA).
  • Collaborate with other departments, including R&D, Production, and Quality Assurance, to resolve product quality issues and support process improvements.
  • Contribute to the preparation and hosting of internal and external audits.
  • Stay abreast of scientific advancements and regulatory changes impacting pharmaceutical quality control.
Requirements
  • Master's or Ph.D. in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related discipline.
  • Minimum of 7 years of experience in pharmaceutical quality control, with at least 2 years in a supervisory or lead role.
  • Extensive hands‑on experience with a wide range of analytical techniques (HPLC, GC-MS, UV-Vis, FTIR, dissolution testing, Karl Fischer titration).
  • Thorough understanding of GMP/GLP principles and regulatory guidelines relevant to pharmaceutical manufacturing in South Africa.
  • Proven ability to develop, validate, and transfer analytical methods.
  • Strong leadership, team management, and interpersonal skills.
  • Excellent analytical, problem‑solving, and decision‑making capabilities.
  • Proficiency in using laboratory information management systems (LIMS) and relevant software.
  • Ability to work effectively in a fast‑paced, deadline‑driven environment in Randburg.
  • Excellent written and verbal communication skills.
Benefits

This role offers a highly competitive salary, comprehensive medical aid, and a generous provident fund contribution. Our client provides excellent opportunities for professional growth and development, including continuous training and exposure to advanced analytical technologies. You will be part of a collaborative and innovative team environment dedicated to producing high‑quality pharmaceuticals. This position is based in Randburg, Gauteng, offering a stable and rewarding career path within a respected pharmaceutical organization. Employees also benefit from performance‑based bonuses and a supportive work culture focused on employee well‑being and success.

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