Job Title: Senior Quality Control Analyst - Pharmaceutical Industry

Job Summary:

As a Senior Quality Control Analyst in the pharmaceutical industry, you will play a pivotal role in ensuring the quality and compliance of pharmaceutical products through the rigorous analysis of raw materials, intermediates, and finished products. This position involves leading a team of analysts, conducting complex analytical testing, and contributing to the continuous improvement of quality control processes.

Key Responsibilities:

1. Team Leadership:
   • Provide leadership and guidance to a team of quality control analysts.
   • Foster a culture of excellence, teamwork, and continuous improvement within the quality control department.
2. Analytical Testing:
   • Perform and oversee a variety of analytical tests, including but not limited to HPLC, GC, ICP, LCMS, and wet chemistry, to ensure compliance with specifications and regulatory standards.
   • Review and interpret analytical data, troubleshoot issues, and ensure the accuracy and reliability of results.
3. Method Development and Validation:
   • Lead or contribute to the development and validation of analytical methods.
   • Stay current with industry advancements and implement new technologies to improve analytical capabilities.
4. Instrumentation and Equipment Management:
   • Ensure the proper operation, calibration, and maintenance of analytical instruments and equipment.
   • Coordinate with maintenance and calibration teams to address any issues promptly.
5. Quality Documentation:
   • Generate, review, and maintain accurate and detailed records of analytical testing and results.
   • Prepare and review method validation protocols and reports.
6. Investigation and Troubleshooting:
   • Lead investigations into out-of-specification results or unexpected trends, implementing corrective and preventive actions.
   • Collaborate with cross-functional teams to resolve quality-related issues.
7. Regulatory Compliance:
   • Stay abreast of relevant regulations (e.g., FDA, ICH) and industry standards.
   • Ensure all quality control activities comply with regulatory requirements and company policies.
8. Continuous Improvement:
   • Identify opportunities for process improvement within the quality control laboratory.
   • Implement and champion initiatives to enhance efficiency and effectiveness.

Qualifications and Experience:

• Bachelor's or advanced degree in Chemistry, Pharmaceutical Sciences, or a related field.
• Several years of experience in a quality control laboratory, with a focus on analytical testing.
• Strong knowledge of analytical techniques and instrumentation.
• Experience in method development, validation, and troubleshooting.
• Leadership experience with the ability to manage and motivate a team.
• Familiarity with cGMP (Current Good Manufacturing Practices) regulations.
• Excellent organizational, communication, and problem-solving skills.

Additional information: Candidates who meet the above conditions can send their CVs to email:  [најави се за да го видиш е-маилот]