Quality Lab Inspector

Profile Data; South Africa; On-site; ZAR 1,000,000 - 1,500,000; Full time

Job summary

Profile Data in East London, Eastern Cape, seeks an experienced Pharmaceutical Quality Control Manager to lead the QC department, ensuring products meet GMP and regulatory standards.

You will manage a team of QC analysts, oversee method development/validation, equipment calibration, CAPAs, and liaise with Production, QA, and R&D to uphold product quality and patient safety.

This leadership role offers significant impact in a reputable pharmaceutical manufacturer with a strong compliance culture.

Qualifications

• Bachelor's or Master's degree in Pharmacy, Chemistry, Analytical Chemistry, or related life science.
• Minimum 7 years in pharmaceutical Quality Control with at least 3 years in supervision/management.
• Extensive GMP knowledge and regulatory understanding.
• Experience with analytical techniques (HPLC, GC, UV-Vis, Karl Fischer).
• Experience in method development, validation, and transfer.
• Strong leadership and communication skills.
• Proficiency in LIMS and standard office software.

Responsibilities

• Lead, manage, and mentor the QC laboratory team.
• Oversee testing of raw materials, in-process samples, and finished products.
• Develop, validate, and transfer analytical methods for new/existing products.
• Ensure GMP compliance and regulatory guidelines (SAHPRA).
• Manage laboratory equipment calibration, maintenance, and qualification.
• Review and approve QC testing records, COAs, and deviation reports.
• Investigate OOS results and implement CAPAs.
• Liaise with Production, QA, and R&D to resolve issues.
• Manage budgets, inventory, and vendor relationships.
• Stay updated on analytical techniques and regulatory requirements.

Skills

Leadership

Problem solving

Decision making

Communication

Team management

Analytical thinking

Regulatory knowledge

Interpersonal skills

Quality culture

Education

Bachelor's or Master's in Pharmacy/ Chemistry/ Analytical Chemistry

Tools

LIMS

Job description

Pharmaceutical Quality Control Manager

Our client, a reputable pharmaceutical manufacturer, is seeking an experienced Pharmaceutical Quality Control Manager to lead their QC department in East London, Eastern Cape. This leadership role is crucial for ensuring that all manufactured pharmaceutical products meet stringent quality standards and regulatory requirements. You will oversee a team of QC analysts, manage laboratory operations, and implement robust quality control procedures. The ideal candidate will possess extensive experience in pharmaceutical quality control, a deep understanding of GMP, and strong leadership and analytical skills. This position offers a significant opportunity to contribute to product quality and patient safety within a well-established company.

Key Responsibilities

• Lead, manage, and mentor the Quality Control (QC) laboratory team, ensuring efficient operation and professional development.
• Oversee the testing of raw materials, in-process samples, and finished products according to established specifications and validated methods.
• Develop, validate, and transfer analytical methods for new products and optimize existing methods.
• Ensure compliance with Good Manufacturing Practices (GMP) and other relevant regulatory guidelines (e.g., SAHPRA).
• Manage laboratory equipment, ensuring proper calibration, maintenance, and qualification.
• Review and approve QC testing records, certificates of analysis, and deviation reports.
• Investigate out-of-specification (OOS) results and implement corrective and preventive actions (CAPAs).
• Liaise with other departments, including Production, Quality Assurance, and R&D, to resolve quality-related issues.
• Manage laboratory budgets, inventory, and vendor relationships.
• Stay updated on the latest advancements in analytical techniques and regulatory requirements within the pharmaceutical industry.

Requirements

• Bachelor's or Master's degree in Pharmacy, Chemistry, Analytical Chemistry, or a related life science discipline.
• A minimum of 7 years of experience in pharmaceutical Quality Control, with at least 3 years in a supervisory or management role.
• Extensive knowledge of GMP, pharmaceutical analysis, and quality control systems.
• Proficiency in various analytical techniques such as HPLC, GC, UV-Vis, Karl Fischer titration, etc.
• Experience in method development, validation, and transfer.
• Strong understanding of regulatory requirements specific to pharmaceutical manufacturing.
• Excellent leadership, team management, problem-solving, and decision-making skills.
• Proficiency in laboratory information management systems (LIMS) and standard office software.
• Strong communication and interpersonal skills, with the ability to interact effectively with all levels of the organization.

Benefits