Job
Description
Overview: We are seeking an experienced QC Manager to oversee and ensure the quality control operations for our API (Active Pharmaceutical Ingredient) manufacturing facility. The ideal candidate will lead QC teams, implement quality standards, and ensure compliance with regulatory requirements to maintain product quality and safety. Key Responsibilities: Lead and supervise the Quality Control department, ensuring efficient and compliant testing and analysis of raw materials, in-process materials, and finished APIs. Develop, review, and approve standard operating procedures (SOPs), work instructions, and validation protocols. Ensure all QC activities comply with regulatory standards such as cGMP, FDA, EMA, and other applicable guidelines. Coordinate and audit laboratory activities, including sampling, testing, and reporting. Investigate and troubleshoot deviations, OOS (out of specification) results, and complaints. Implement continuous improvement initiatives to enhance QC laboratory efficiency and data integrity. Manage calibration and qualification of laboratory instruments and equipment. Maintain documentation and records in accordance with regulatory requirements. Liaise with production, R&D, and other departments to support quality-related activities. Ensure training and development of QC staff on GMP, compliance, and technical procedures. Prepare quality reports, metrics, and documentation for audits and inspections. Qualifications: Bachelor's or Master's degree in Chemistry, Pharmacy, Pharmaceutical Sciences, or a related field. Proven experience (15+ years) in QC within the pharmaceutical or API industry. Strong knowledge of cGMP, regulatory standards, and validation processes. Leadership skills with the ability to manage a team effectively. Excellent analytical, problem-solving, and communication skills. Experience with laboratory instrumentation and data systems. Preferred: Experience working with regulatory audits and inspections. Knowledge of Quality Management Systems (QMS).
