Quality Control Manager

Urgently Required

Quality Control Manager

Experience :  1 to 5 years

No of vacancies :  1

Job Description: The Quality Control Manager is responsible for overseeing and managing all quality control activities in a pharmaceutical facility, ensuring that raw materials, in-process samples, and finished products meet regulatory and quality standards. This role involves implementing quality control systems, managing laboratory operations, and ensuring compliance with GMP and regulatory requirements.

Key Responsibilities: Quality Testing Oversight: Manage and oversee testing of raw materials, in-process samples, and finished products to ensure compliance with Indian Pharmacopeia (IP) and international standards.
Laboratory Management: Supervise quality control laboratory operations, ensuring timely and accurate testing results.
Regulatory Compliance: Ensure all QC activities comply with GMP, Schedule M, WHO-GMP, and international regulations (USFDA, EMA, etc.).
Documentation: Review and approve analytical reports, certificates of analysis, and other QC documentation.
Equipment Calibration: Ensure all laboratory equipment is properly calibrated and maintained.
Method Validation: Oversee validation of analytical methods to ensure reliability and accuracy.
Internal and External Audits: Prepare for and participate in audits by regulatory authorities and customers.
Team Management: Lead, train, and mentor QC staff, fostering a culture of accuracy and excellence.
Deviation Management: Investigate and resolve deviations, OOS (Out of Specification), and OOT (Out of Trend) results.
Continuous Improvement: Implement initiatives to enhance testing efficiency and quality standards.

Education Qualifications: Minimum Requirements: Bachelor’s degree in Pharmaceutical Sciences, Chemistry, or Microbiology.
Preferred: Master’s degree in Analytical Chemistry or a related field.
Certifications: GMP, ISO 17025, or other relevant certifications are advantageous.
Experience: Proven experience in quality control roles, preferably in the pharmaceutical industry.

Key Attributes: Detail-Oriented: Precision in reviewing test results and documentation.
Analytical Skills: Strong understanding of analytical methods and problem-solving capabilities.
Regulatory Knowledge: Familiarity with GMP, WHO-GMP, and international quality standards.
Leadership: Proven ability to lead and manage a quality control team.
Communication: Proficient in reporting and cross-departmental collaboration.

About the Role: The Quality Control Manager ensures that all testing and laboratory activities in the pharmaceutical facility meet regulatory standards and organizational quality objectives. This role is critical in maintaining product quality, supporting regulatory compliance, and fostering a culture of excellence within the QC team. The manager plays a vital role in ensuring that the products meet quality specifications and are safe for distribution.