Position Details

Key Responsibilities:

•    Supervise daily operations of the QC lab, ensuring all activities align with company protocols and regulatory requirements.
•    Train, mentor, and evaluate the performance of laboratory technicians and other staff.
•    Develop and implement standard operating procedures (SOPs) to maintain high-quality standards.
•    Coordinate with other departments to ensure seamless workflow and communication.
•    Review and approve test results before batch release of product.
•    Identify and address any deviations from SOPs or regulatory standards.
•    Implement corrective actions to resolve any issues and prevent recurrence.
•    Ensure compliance with all relevant EU GMP regulations.
•    Oversee the validation and verification of new testing procedures and technologies.
•    Troubleshoot technical issues and provide solutions.
•    Maintain accurate and detailed records of all QC activities.
•    Generate and analyze data reports to monitor lab performance.
•    Present findings to senior management and make recommendations for improvements as identified.
•    Must adhere to safety protocols and wear appropriate protective equipment.
•    Proficient in physical, chemical and virological testing techniques and methodologies.
•    Strong understanding of regulatory standards and compliance.
•    Ability to analyze and interpret complex data.
•    Excellent leadership and team management abilities.
•    Strong communication and interpersonal skills.
•    Detail-oriented with a high level of accuracy.
•    Problem-solving and critical thinking skills.
•    Other duties as assigned. 

Job Specific Technical, Functional and Professional Competencies:
Technical/Professional Knowledge: Have achieved a satisfactory level of technical and professional skill or knowledge in position related areas, keep up with current developments and trends in areas of expertise. Strong technical knowledge as it applies to Analytical Method Development, Analytical Method Validation and Statistical Quality Control. An understanding of GMP, ICH and compendia regulations and guidance’s.

Planning and Organising.

Decision Making/Problem Solving: Identify and understand issues, problems and opportunities and compare data from different sources to draw conclusions and develop solutions consistent with the facts.

Essential Education and Experience:
•    Bachelor’s degree in Pharmaceutical Science, , Biology, Chemistry, or a related science field. A Master’s degree is preferred.
•    Minimum of 5 years of quality control lab experience.
•    Experience in a supervisory or management role.
•    Minimum of 2 years of supervision experience.