Job
Description
Company Overview: We are a reputed pharmaceutical company specializing in the manufacturing of Oral Solid Dosage (OSD) formulations. Committed to high-quality standards and regulatory compliance, we are looking for a dynamic and experienced professional to join our Quality Control team. Job Purpose: The Assistant Manager Quality Control will oversee and manage day-to-day QC operations to ensure compliance with cGMP, GLP, and regulatory requirements for OSD manufacturing. This role is critical for maintaining product quality and supporting internal and external audits. Key Responsibilities: Supervise and lead a team of QC analysts and chemists in routine testing of raw materials, in-process samples, finished products, and stability samples. Review and approve analytical data, reports, and documentation in compliance with regulatory standards (USFDA, MHRA, EU, etc.). Ensure adherence to SOPs and perform periodic reviews and updates of QC procedures. Investigate out-of-specification (OOS), out-of-trend (OOT), and laboratory incidents, and implement CAPA. Coordinate and support analytical method validation, method transfer, and instrumentation qualification. Maintain and calibrate laboratory instruments such as HPLC, GC, UV, IR, and Dissolution testers. Assist in audit readiness and participate in regulatory and customer audits. Maintain LIMS or other data management systems effectively. Prepare and deliver periodic training sessions for QC staff. Desired Candidate Profile: Education: M.Sc. (Chemistry), B.Pharm, or M.Pharm Experience: 6–10 years in Quality Control within a regulated OSD manufacturing environment Skills: Hands-on experience with HPLC, GC, and other analytical instruments Sound understanding of cGMP, GLP, ICH guidelines Good documentation and review skills Proficiency in handling OOS/OOT and deviations Strong communication, leadership, and team management abilities Why Join Us? Opportunity to work in a growing, globally compliant pharma facility Competitive salary and performance-based incentives Strong focus on career development and technical training
