Quality Control (QC) Head

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Job Summary:

Key Responsibilities:

1. Lead and manage the Quality Control department, providing guidance and direction to ensure the timely and accurate testing of raw materials, intermediates, and finished products.

2. Develop and implement quality control strategies, policies, and procedures in alignment with regulatory requirements and company standards.

3. Establish and maintain a robust Quality Control laboratory infrastructure, including equipment calibration, validation, and maintenance.

4. Coordinate with cross-functional teams, including Quality Assurance, Manufacturing, and Regulatory Affairs, to support product release and regulatory submissions.

5. Oversee the qualification and validation of analytical methods, ensuring their suitability for use in product testing.

6. Conduct risk assessments and investigations into deviations, out-of-specification (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPAs) as necessary.

7. Manage and develop QC personnel, including hiring, training, performance evaluation, and career development.

8. Ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant regulatory guidelines.

9. Prepare for and participate in regulatory inspections and audits, acting as the primary point of contact for regulatory agencies such as the US Food and Drug Administration (USFDA).

10. Drive a culture of continuous improvement within the Quality Control department, identifying opportunities for process optimization and efficiency gains.

Qualifications and Experience:

• Bachelor's degree in Pharmacy, Chemistry, or related field; advanced degree (e.g., Master's or PhD) preferred.
• Minimum of 15 years of experience in pharmaceutical quality control, with at least 5 years in a leadership role.
• Extensive knowledge of quality control principles, practices, and regulations applicable to the pharmaceutical industry, particularly in regulated markets.
• Experience with regulatory inspections and audits, including preparation, execution, and response to findings.
• Strong communication, interpersonal, and leadership skills, with the ability to collaborate effectively across functions and levels of the organization.