Quality Control Engineer (Pharma Division)-GandhiNagar

Job Description

Industry Preference (Mandatory) Applicants must have prior work experience in at least one of the following regulated manufacturing sectors: Sterile/Injectables Manufacturing Medical Devices Manufacturing Medicinal Equipment Manufacturing Position Overview We are looking for a proactive and detail-driven Quality Control (QC) Engineer with 35 years of experience in Sterile/Injectables , Medical Devices , or Medicinal Equipment manufacturing environments. This role is critical to ensuring consistent product quality through comprehensive analytical testing and adherence to stringent regulatory standards. The ideal candidate will have hands-on expertise in chemical analysis, pharmacopeial testing, and GMP-compliant documentation, especially within a sterile or cleanroom environment. Key Responsibilities Conduct routine testing of raw materials, in-process samples, and finished products in accordance with pharmacopeial guidelines (IP/BP/USP/Ph. Eur.). Perform detailed Pharma Copea Testing including identification, assay, dissolution, impurity profiling, and other analytical parameters. Execute general wet chemistry procedures along with pH and conductivity testing . Operate and calibrate analytical instruments including IR Spectroscopy , STIR , and related chemical analysis equipment. Ensure strict compliance with Good Manufacturing Practices (GMP) , Good Laboratory Practices (GLP) , and internal Standard Operating Procedures (SOPs) . Maintain complete and accurate documentation including test reports, calibration records, instrument logs, and change control records. Support investigations related to Out of Specification (OOS) and Out of Trend (OOT) results, including root cause analysis and CAPA. Liaise with Quality Assurance (QA) , Production , and R&D teams for resolution of analytical issues and technical support. Prepare for and participate in internal and external audits, ensuring full laboratory compliance and readiness. Manage sample collection, labeling, storage, and contribute to stability studies where applicable. Candidate Requirements Educational Qualification (Preferred): B.Sc / M.Sc in Chemistry B.Pharm / M.Pharm with a focus on Pharmaceutical Chemistry Experience: 3–5 years of relevant experience in a pharmaceutical or regulated manufacturing environment Must have worked in Sterile , Injectables , Medical Devices , or Medical Equipment manufacturing Technical Skills: In-depth knowledge of pharmacopeial testing methods and documentation practices Hands-on experience with IR Spectroscopy, STIR, pH meters, and conductivity meters Familiarity with analytical method validation and instrument calibration Strong understanding of Data Integrity , GDP (Good Documentation Practices) , and compliance in regulated cleanroom settings