Job
Description
Job Title: Quality Control (QC) Engineer Department: Quality Control Location: Gandhinagar Reporting To: Senior QC Engineer Experience Required: 3–5 years Industry Preference (Mandatory): Sterile/Injectables, Medical Devices, or Medicinal Equipment Manufacturing Position Overview We are seeking a skilled and detail-oriented Quality Control (QC) Engineer with 3–4 years of hands-on experience in Sterile/Injectables , Medical Devices , or Medicinal Equipment manufacturing. The selected candidate will be responsible for day-to-day quality testing, compliance with pharmacopeial standards, and ensuring adherence to regulatory and GMP/GLP norms. This role is critical to maintaining the integrity and safety of pharmaceutical products by performing thorough chemical testing and documentation in a regulated environment. Key Responsibilities Perform day-to-day testing of raw materials, in-process samples, and finished products in accordance with pharmacopeial standards (IP/BP/USP/Ph. Eur.). Conduct comprehensive Pharma Copea Testing including identification, assay, dissolution, impurity profiling, and other critical parameters. Carry out general wet chemistry tests along with pH method and conductivity testing. Operate and maintain laboratory instruments such as IR Spectroscopy, STIR, and other analytical tools. Ensure strict compliance with GMP/GLP guidelines, regulatory norms, and internal Standard Operating Procedures (SOPs). Prepare and maintain accurate documentation including test reports, calibration records, instrument usage logs, and change controls. Participate in investigations for Out of Specification (OOS) and Out of Trend (OOT) results, and support the implementation of corrective and preventive actions (CAPA). Coordinate with Quality Assurance (QA), Production, and R&D teams for technical clarifications and analytical issue resolutions. Participate in internal and external audits, ensuring laboratory readiness and compliance at all times. Manage sample collection, proper labeling, storage, and contribute to stability studies as required. Candidate Requirements Preferred: Bachelor’s or Master’s degree in Chemistry (B.Sc / M.Sc), B.Pharm or M.Pharm with a specialization in Pharmaceutical Chemistry. Minimum 3–4 years of relevant experience in a pharmaceutical or allied regulated manufacturing setup. Mandatory prior experience in any of the following industries: Sterile/Injectables Manufacturing Medical Devices Manufacturing Medicinal Equipment Manufacturing Proficient in analytical techniques and equipment such as IR, STIR, pH meters, and conductivity meters. Sound knowledge of instrument calibration and analytical method validation. Strong documentation skills with adherence to Good Documentation Practices (GDP) and data integrity principles. Experience working in cleanroom and sterile environments under regulatory requirements. Employment Terms Employment Type: Full-time Working Days: [6 days/week] Compensation: [6-6.5 LPA] Location: [Gandhinagar] Application Process Interested and eligible candidates who meet the above criteria are invited to submit their updated CV to [hr2@gopani.com]. Please mention “Application for QC Engineer – Sterile/Medical Devices” in the subject line of your email. Show more Show less
