Quality Control (QC) Manager at HRLeverage Africa

Job Description

• We are seeking an experienced and dynamic Quality Control (QC) Manager to lead our QC team at our pharmaceutical factory.
• The QC Manager will be responsible for overseeing all aspects of quality control testing and analysis to ensure compliance with regulatory requirements and quality standards.

Key Responsibilities
Quality Control Operations:

• Oversee and coordinate all QC testing and analysis activities, including raw materials, in-process samples, and finished products, to ensure compliance with established specifications and standards.
• Develop, implement, and maintain robust quality control processes, procedures, and systems to ensure the accuracy, reliability, and reproducibility of test results.

Regulatory Compliance:

• Ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and regulatory requirements from agencies such as the FDA, EMA, and ICH guidelines.
• Participate in internal and external audits, inspections, and regulatory submissions as needed.

Method Development and Validation:

• Oversee the development and validation of analytical test methods for QC testing in accordance with regulatory requirements and industry standards.
• Evaluate and implement new technologies, instrumentation, and methodologies to enhance the efficiency and effectiveness of QC operations.

Quality Assurance Support:

• Collaborate closely with the Quality Assurance (QA) team to investigate deviations, out-of-specification results, and quality-related issues, and implement corrective and preventive actions (CAPAs) as needed.
• Provide technical expertise and support for investigations, root cause analysis, and risk assessments related to quality control activities.

Training and Development:

• Train, mentor, and develop QC staff to ensure competency and proficiency in analytical techniques, equipment operation, and quality control procedures.
• Foster a culture of continuous improvement, professionalism, and accountability within the QC team.

Documentation and Record Keeping:

• Maintain accurate and complete records of all QC testing activities, including test results, observations, deviations, and corrective actions, in accordance with SOPs and regulatory guidelines.

Qualifications and Skills

• Bachelor's degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or related field. Advanced degrees (e.g., Master's or Ph.D.) are preferred.
• Minimum of [X] years of experience in a pharmaceutical QC laboratory, with progressive experience in a supervisory or managerial role.
• Strong knowledge of analytical techniques, instrumentation, and methodologies commonly used in pharmaceutical QC testing (e.g., HPLC, GC, UV-Vis spectroscopy, dissolution testing).
• Thorough understanding of regulatory requirements, quality standards, and compliance principles related to pharmaceutical quality control.
• Excellent leadership, communication, and interpersonal skills, with the ability to motivate and inspire a diverse team.
• Strong problem-solving abilities, decision-making skills, and attention to detail.
• Ability to effectively manage multiple priorities and deadlines in a fast-paced, regulated environment.

Working Conditions:

• The job may require standing or sitting for extended periods in a laboratory or office setting.
• Flexible working hours may be required to accommodate production schedules and testing priorities.