Officer/ Executive - QC

As a Quality Control Analyst at Global Calcium Pvt. Ltd., your role is crucial in maintaining the quality of pharmaceutical products, particularly in the API (Oncology) sector. Your responsibilities will include: - Performing analysis of various materials including raw materials, intermediates, finished products, and stability samples - Operating and maintaining a range of analytical instruments such as HPLC (Shimadzu, Agilent, Empower, Chromeleon), GC, IR, UV, Moisture Balance, Karl Fischer (KF), and Potentiometric Titration - Conducting analytical investigations like System Suitability Tests, Laboratory Investigations, OOS, OOT analysis, Root Cause Analysis, and CAPA implementation - Ensuring compliance with GMP, GLP, and regulatory standards from FDA, WHO, ICH - Maintaining accurate documentation and data integrity to meet audit and inspection requirements - Collaborating with QA, ADL, R&D, and Production teams for process improvements - Identifying documentation gaps and suggesting improvements for compliance and efficiency - Supporting internal and external audits through proactive documentation and team coordination Key Skills & Competencies required for this role include: - Strong analytical and documentation skills - In-depth knowledge of cGMP/GLP and regulatory guidelines - Proficiency in using analytical software such as LabSolutions, Empower, Chromeleon - Detail-oriented mindset with a focus on quality and data accuracy - Excellent problem-solving and root cause analysis abilities - Effective team player with good communication and interpersonal skills Qualifications for this position include: - Educational Qualification: MSc / BSc in Chemistry / Analytical Chemistry - Experience: 3 to 5 years in Quality Control Industry experience in Pharma Bulk Drug / API / API oncology is preferred. Your role will involve ensuring compliance with GMP, GLP, and regulatory requirements from FDA, WHO, and ICH, as well as hands-on experience with various analytical instruments and meticulous documentation practices.,