Lead Quality Control Analyst - Pharmaceutical Manufacturing

Placements24; George; On-site; ZAR 900,000 - 1,200,000; Full time

Benefits offered by this job

Competitive remuneration package

Medical aid plan

Provident fund

Performance-based incentives

Job summary

Placements24 is seeking a Lead Quality Control Analyst for a prominent pharmaceutical manufacturer in George, Western Cape. The role oversees the QC laboratory operations, ensuring products meet regulatory and internal quality specs before release.

A hands-on leader is required to manage analytical techniques and GMP guidelines on-site. The successful candidate will guide testing, method validation, data integrity, and CAPA processes, while collaborating with Production, Regulatory, and QA teams

Qualifications

• 7+ years of progressive experience in pharmaceutical quality control, with at least 3 years in a leadership or supervisory role.
• Hands-on experience with analytical instrumentation (HPLC, GC, FTIR, UV-Vis, Dissolution) and regulatory requirements.
• Strong knowledge of GMP/GLP and SAHPRA requirements; ability to develop/validate analytical methods.

Responsibilities

• Lead, train, and mentor a team of QC Analysts, ensuring accurate testing and protocol adherence.
• Develop, validate, and implement analytical methods for raw materials, in-process samples, and finished products.
• Oversee routine testing with HPLC, GC, UV-Vis, titration, and dissolution testing.
• Ensure GMP/GLP compliance and participate in audits as SME for QC.

Skills

Leadership

Data integrity

Problem solving

Communication

Team management

GMP knowledge

Education

Bachelor's or Master's degree in Chemistry, Pharmacy, or related field

Tools

LIMS

Job description

About the Role

Our client, a prominent pharmaceutical manufacturer located in George, Western Cape , is actively seeking a highly skilled and experienced Lead Quality Control Analyst . This critical role is responsible for overseeing all aspects of the quality control laboratory operations, ensuring that all manufactured pharmaceutical products meet stringent regulatory standards and internal quality specifications before release to the market. The successful candidate will play a vital part in maintaining the integrity and safety of our client's product portfolio. This position requires a hands-on leader with a deep understanding of analytical techniques and GMP guidelines within the pharmaceutical industry. The role is based in our state-of-the-art facility in George and demands a strong on-site presence to effectively manage laboratory activities and personnel.

Key Responsibilities

• Lead, train, and mentor a team of Quality Control Analysts, ensuring efficient and accurate execution of testing protocols.
• Develop, validate, and implement analytical methods for raw materials, in-process samples, and finished pharmaceutical products according to pharmacopeial standards and regulatory requirements.
• Oversee routine testing using techniques such as HPLC, GC, UV-Vis spectroscopy, titration, and dissolution testing.
• Ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and all relevant regulatory guidelines (e.g., SAHPRA).
• Investigate Out-of-Specification (OOS) results, identify root causes, and implement corrective and preventative actions (CAPAs).
• Maintain laboratory equipment, ensuring proper calibration, qualification, and maintenance schedules are followed.
• Manage inventory of laboratory consumables and reagents, ensuring adequate stock levels.
• Review and approve analytical data, laboratory notebooks, and QC reports.
• Collaborate with other departments, including Production, Formulation Development, and Regulatory Affairs, to resolve quality issues.
• Participate in internal and external audits as a subject matter expert for the QC department.

Requirements

• Bachelor's or Master's degree in Chemistry, Pharmacy, or a related scientific field.
• Minimum of 7 years of progressive experience in pharmaceutical quality control, with at least 3 years in a leadership or supervisory role.
• Extensive hands-on experience with a variety of analytical instrumentation (HPLC, GC, FTIR, UV-Vis, Dissolution apparatus).
• In-depth knowledge of GMP, GLP, and relevant pharmaceutical regulatory requirements, particularly those set by SAHPRA.
• Proven ability to develop and validate analytical methods.
• Strong problem-solving skills with a systematic approach to OOS investigations and CAPA implementation.
• Excellent understanding of data integrity principles and laboratory documentation practices.
• Exceptional leadership, team management, and communication skills.
• Proficiency in laboratory information management systems (LIMS) is an advantage.
• Must be willing to work on-site in George, Western Cape , and be available for occasional extended hours as required by production schedules.

Benefits

Our client is committed to providing a rewarding career opportunity with a competitive remuneration package, including a comprehensive medical aid plan, provident fund, and performance-based incentives. You will have the chance to work in a modern, well-equipped laboratory with opportunities for professional growth and training. The company culture emphasizes collaboration, continuous improvement, and employee well-being. This role offers the stability of working for a well-established pharmaceutical company in the beautiful region of the George, Western Cape , contributing to the health and safety of the public through ensuring product quality.