Quality Control Officer

Job Title Quality Control Officer Location Mehsana Gujrat About Celogen Celogen Pharma Pvt Ltd is a leading pharmaceutical formulations exporter manufacturer based in India The company provides it products and services in multiple countries globally including West Africa East Africa South Asia South East Asia the Middle East South America Europe Apart from promoting our branded products in the retail sector we also participate in a number of global tenders in a number of countries The team comprises of a group of first generation marketing expats and some of the best technocrats in the field The company has four manufacturing bases in India manufacturing a variety of products This job posting is in a hormone formulation manufacturing division of Celogen Pharma Job Summary The Quality Control Officer will be a key member of our Quality Control team responsible for ensuring the highest standards of quality for our pharmaceutical products from raw materials to finished goods This role involves the execution and oversight of various analytical tests data review documentation and active participation in laboratory investigations and continuous improvement initiatives The ideal candidate will have a strong background in pharmaceutical QC excellent analytical skills and a thorough understanding of cGLP guidelines Responsibilities Analytical Testing Perform routine and non-routine analytical testing of raw materials in-process samples finished products stability samples and packaging materials using various analytical techniques e g HPLC GC UV-Vis FTIR KF Dissolution Titration Physical testing Ensure all testing is conducted in accordance with approved pharmacopoeial methods and in-house specifications Operate calibrate and maintain analytical instruments ensuring their optimal performance and readiness for testing Data Review Documentation Thoroughly review analytical data raw data and laboratory notebooks for accuracy completeness and compliance with established procedures and regulatory requirements Prepare and review Certificates of Analysis COAs and other relevant quality documents Ensure timely and accurate documentation of all testing activities results and observations Maintain detailed and organized laboratory records Investigations Deviations Participate in Out-of-Specification OOS and Out-of-Trend OOT investigations identifying root causes and recommending corrective and preventive actions CAPAs Document and investigate laboratory deviations ensuring adherence to established procedures Support the implementation and verification of CAPAs Method Development Validation Support Assist in the development transfer and validation of analytical methods as per regulatory guidelines Conduct feasibility studies and provide technical input for method optimization Compliance Audits Ensure strict adherence to current Good Manufacturing Practices cGMP Good Laboratory Practices GLP and other applicable regulatory guidelines e g FDA MHRA WHO Participate in internal and external audits e g regulatory inspections customer audits by providing necessary documentation and technical support Address audit observations and implement corrective actions Training Mentorship May assist in training junior QC analysts on analytical techniques instrument operation and laboratory procedures Serve as a technical resource for other team members Safety Housekeeping Comply with all laboratory safety procedures and guidelines Maintain a clean organized and safe working environment Manage laboratory waste in accordance with environmental regulations Continuous Improvement Identify opportunities for process improvements and efficiency enhancements within the QC laboratory Contribute to the revision and creation of Standard Operating Procedures SOPs and other quality documents Qualifications Education Bachelor s or Master s degree in Pharmacy Analytical Chemistry Chemistry or a related scientific discipline Experience 1-2 years of progressive experience in Quality Control within a pharmaceutical manufacturing environment Skills Competencies Proficient in operating and troubleshooting a wide range of analytical instruments HPLC GC UV-Vis FTIR KF Dissolution apparatus etc Strong understanding of analytical method validation and transfer principles Experience with LIMS Laboratory Information Management System is highly desirable Proficiency in Microsoft Office Suite Word Excel PowerPoint In-depth knowledge of cGMP GLP and regulatory requirements e g ICH guidelines Excellent analytical problem-solving and critical thinking skills Strong attention to detail and accuracy Ability to work independently and as part of a team in a fast-paced environment Excellent written and verbal communication skills Strong organizational and time management skills Experience with specific pharmaceutical dosage forms e g tablets capsules injectables liquids Familiarity with Data Integrity principles Certification in Six Sigma or Lean Manufacturing is a plus Job Type Full-time Pay 45 000 00 - 50 000 00 per month Ability to commute relocate Mehsana Gujarat Reliably commute or planning to relocate before starting work Required Application Question s Do you know how to operate an HPLC system Work Location In person