QCM- API Pharmaceuticals

Description

The successful candidate will be responsible for managing all aspects of laboratory operations including testing, validation, documentation, and audit coordination. The role demands hands-on expertise with sophisticated analytical instruments such as HPLC, GC, UV spectroscopy, and Karl Fischer titration. The Quality Control Manager also plays a vital role in supervising and training the QC team, leading investigations on quality deviations, and supporting product method development and validation efforts. This position requires a proactive leader who can uphold quality standards while optimizing laboratory performance and ensuring readiness for regulatory inspections.

Responsibilities

• Oversee comprehensive testing of raw materials, in-process samples, and finished APIs including assays, related substances, limit of detection, particle size, and residual solvents to ensure product quality.
• Review, approve, and verify analytical test results, certificates of analysis, and batch release documentation in compliance with pharmacopeial and internal standards.
• Ensure all laboratory operations comply rigorously with current Good Manufacturing Practices (cGMP), USP, BP, EP, and applicable regulatory guidelines.
• Manage calibration, validation, preventive maintenance, and troubleshooting of analytical laboratory instruments such as High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Ultraviolet (UV) Spectrophotometer, and Karl Fischer titrator to maintain reliable performance.
• Lead thorough investigations of out-of-specification (OOS) and out-of-trend (OOT) analytical results, implementing corrective and preventive actions as necessary to resolve quality issues.
• Develop, review, and approve Standard Operating Procedures (SOPs), specification documents, and analytical methods to conform to regulatory and industry standards.
• Train, mentor, and supervise a team of approximately 20 QC chemists and analysts to enhance technical skills, quality awareness, and adherence to safety standards.
• Coordinate effectively with internal departments and external regulatory bodies during audits and inspections, ensuring transparent documentation and prompt resolution of findings.
• Maintain and oversee stability study programs and retention sample policies to validate product shelf life and support ongoing quality assurance.
• Support the validation and transfer of new analytical methods for product development and process improvements in collaboration with R&D and Production departments.

Experience

8 Years

Apply By

Oct 29, 2026

Required Skills

• Quality Control Manager (QCM) – API Manufacturing
• Pharmaceutical Quality Control
• USP/BP/EP Standards
• Current Good Manufacturing Practices (cGMP)
• High Performance Liquid Chromatography (HPLC)
• Gas Chromatography (GC)
• Ultraviolet Spectrophotometry (UV)
• Karl Fischer titration
• Analytical Method Validation
• Regulatory Audit Management
• Investigation of OOS/OOT results

Nice to Have Skills

• Team Leadership
• Documentation and Reporting
• Stability Studies Management
• Standard Operating Procedures (SOP) Development