Quality Control Manager-pharmaceutical

Recruit AI is seeking an experienced Quality Control Manager to lead the Quality Control department at Livewell Capsules Pvt. Ltd., a manufacturer of empty hard gelatine capsules. This key leadership position oversees testing of raw materials, in-process production, and finished goods to ensure strict compliance with GMP and ISO 9001 quality standards. The successful candidate will manage a team of five professionals and maintain high-quality manufacturing processes while supporting continuous improvement initiatives. The Quality Control Manager plays a critical role in maintaining regulatory compliance across all operations, including vendor qualification, supplier quality management, and audit coordination. This opportunity allows the candidate to work closely with senior management and cross-departmental teams such as Production, Research and Development, and Procurement. Strong analytical, problem-solving, and team management skills are essential to drive root cause analysis, corrective and preventive actions, and quality documentation within a dynamic pharmaceutical manufacturing environment.
Responsibilities

Lead and manage the Quality Control department, including a team of five professionals, ensuring departmental goals align with company objectives.
Develop, implement, and maintain Standard Operating Procedures (SOPs) for quality control testing, sampling, and documentation of raw materials, in-process samples, and finished products according to defined specifications.
Ensure continual compliance with Good Manufacturing Practices (GMP) and ISO 9001 quality management system requirements through rigorous oversight and quality assurance activities.
Oversee the calibration, validation, and maintenance of laboratory instruments and quality control equipment to guarantee accurate and reliable test results.
Investigate quality deviations, out-of-specification (OOS) results, and customer complaints by conducting thorough root cause analysis and implementing effective corrective and preventive actions (CAPA).
Prepare and maintain comprehensive quality documentation, batch records, and audit trails needed for internal use and external regulatory or customer audits.
Coordinate and lead internal audits and support external audits and inspections conducted by regulatory authorities, customers, and certification bodies to uphold compliance standards.
Train, mentor, and develop quality control staff on testing protocols, documentation standards, regulatory compliance, and continuous improvement methodologies.
Collaborate with cross-functional teams including Production, Research and Development, and Procurement to resolve quality issues and support quality improvement projects targeting operational excellence.
Monitor supplier and raw material quality by managing supplier qualification processes and conducting supplier quality assessments and audits.
Report quality metrics, trends, and key performance indicators (KPIs) to senior management, highlighting quality system effectiveness and areas for improvement.
Stay current with evolving pharmaceutical quality regulations, industry best practices, and technological developments to recommend and implement enhancements to the quality management system.