Lead Pharmaceutical Quality Control Analyst

Placements24; George; On-site; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Competitive remuneration

Medical aid options

Provident fund

Life insurance

Career progression

Generous annual leave

Job summary

Placements24 seeks a Lead Pharmaceutical Quality Control Analyst to oversee QC operations in George. Lead a team, develop testing methods, and ensure cGMP compliance to guarantee product quality and patient safety.

The role requires 7+ years in pharmaceutical QC, with supervisory experience, and deep knowledge of analytical instrumentation and QA systems. Competitive package with growth opportunities in the Western Cape region.

Qualifications

• Master's degree or Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or a related field.

Responsibilities

• Lead, train, and mentor a team of Quality Control Analysts, ensuring high performance and SOP adherence.
• Develop, validate, and implement analytical test methods for raw materials, in-process samples, and finished products using HPLC, GC, UV-Vis, and FTIR.
• Oversee routine QC testing with timely and accurate results.
• Investigate out-of-specification results and implement CAPAs.
• Ensure all QC activities comply with cGMP, ICH guidelines, and regulatory requirements.
• Manage calibration, maintenance, and qualification of analytical lab equipment.
• Review and approve analytical data, specifications, and stability reports.
• Participate in audits as a subject matter expert for QC operations.
• Contribute to continuous QC process improvements and regulatory compliance.
• Maintain comprehensive laboratory records compliant with regulatory standards.

Skills

Leadership

Team mentoring

Communication

SPC & data analysis

Troubleshooting

Regulatory awareness

Education

MSc/PhD in Analytical Chemistry or related

Tools

HPLC

GC

KF titration

Dissolution testing

LIMS

Job description

About the Role

Our client is a premier pharmaceutical organization seeking a highly motivated and detail-oriented Lead Pharmaceutical Quality Control Analyst to oversee critical quality assurance operations at their facility in George . This leadership role is essential for ensuring the consistent quality, safety, and efficacy of all manufactured pharmaceutical products. The successful candidate will be responsible for managing a team of QC analysts, developing and implementing robust testing protocols, and ensuring compliance with all relevant regulatory standards. This position offers a unique opportunity to contribute to the integrity of pharmaceutical manufacturing in the beautiful region of the Western Cape , specifically in George . We are looking for an individual with a strong background in analytical chemistry, quality control methodologies, and a deep understanding of GMP (Good Manufacturing Practices) within the pharmaceutical industry. Your leadership will directly impact product quality and patient safety, making this a role of significant importance.

Key Responsibilities

• Lead, train, and mentor a team of Quality Control Analysts, ensuring high performance and adherence to SOPs.
• Develop, validate, and implement analytical test methods for raw materials, in-process samples, and finished pharmaceutical products using techniques such as HPLC, GC, UV-Vis, and FTIR.
• Oversee routine QC testing, ensuring timely and accurate results are generated and documented.
• Investigate out-of-specification (OOS) results, identify root causes, and implement corrective and preventive actions (CAPAs).
• Ensure all QC activities comply with current Good Manufacturing Practices (cGMP), ICH guidelines, and other relevant regulatory requirements.
• Manage the calibration, maintenance, and qualification of analytical laboratory equipment.
• Review and approve analytical data, specifications, and stability reports.
• Participate in internal and external audits, acting as a subject matter expert for QC operations.
• Contribute to the continuous improvement of QC processes and systems to enhance efficiency and reliability.
• Maintain comprehensive laboratory records and documentation in accordance with regulatory standards.

Requirements

• Master's degree or Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or a related field.
• 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 instrumentation, including HPLC, GC, KF titrators, and dissolution apparatus.
• In-depth knowledge of cGMP, FDA regulations, and ICH guidelines pertaining to pharmaceutical manufacturing and quality control.
• Proven experience in method validation and transfer.
• Strong understanding of statistical process control (SPC) and data analysis.
• Excellent leadership, communication, and interpersonal skills.
• Demonstrated ability to troubleshoot analytical issues and implement effective solutions.
• Proficiency in LIMS and other relevant quality management software.
• Detail-oriented with a strong commitment to accuracy and compliance.

Benefits

• This role offers a competitive remuneration package, including an attractive annual salary, performance incentives, and a comprehensive benefits scheme.
• The benefits include extensive medical aid options, a provident fund, and life insurance.
• We are committed to employee development, providing access to advanced training programs, industry conferences, and opportunities for career progression within our organization.
• A healthy work-life balance is encouraged, with ample annual leave.
• Employees can also benefit from wellness initiatives and potential on-site amenities.

Our client is an equal opportunity employer and values diversity within its workforce.

This is a unique chance to advance your career in quality control within a respected pharmaceutical company located in the scenic town of George .