Quality Control Head

Job Title Quality Control Head Location Mehsana Gujrat About Company 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 Head of Quality Control QC is a senior leadership position responsible for directing all laboratory operations related to the testing of raw materials packaging materials in-process materials and finished pharmaceutical products This role ensures that all quality control activities are conducted in strict compliance with current Good Laboratory Practices GLP and all applicable national and international regulatory standards The successful candidate will drive the strategic direction of the QC function ensuring high-quality timely analytical support for manufacturing and product release Responsibilities 1 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 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 2 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 3 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 4 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 5 Compliance Audits Ensure strict adherence to current Good Manufacturing Practices cGMP Good Laboratory Practices GLP and other applicable regulatory guidelines 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 6 Training Mentorship Train junior QC analysts on analytical techniques instrument operation and laboratory procedures Serve as a technical resource for other team members 7 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 8 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 9 Strategic Leadership Management Establish Strategic Direction Develop and execute the long-term strategy for the QC department aligning it with the company s overall business and quality objectives Team Leadership Lead mentor and manage the QC team fostering a culture of quality compliance and continuous improvement Manage department budget resources and personnel development Laboratory Oversight Oversee the daily operations of the QC laboratory including scheduling resource allocation and maintaining laboratory infrastructure instrumentation and environment 10 Regulatory Compliance Quality Systems Compliance Assurance Ensure all QC testing documentation investigations and releases comply with cGMP GLP Pharmacopoeial requirements e g USP EP JP and regulatory filings Audit Management Serve as the primary QC representative during regulatory inspections e g FDA MHRA EMA and internal external audits Ensure timely and effective closure of all QC-related audit observations and CAPAs Documentation Control Review and approve critical QC documentation including Standard Operating Procedures SOPs test methods specifications method validation transfer protocols and reports and stability protocols 11 Analytical Operations Data Integrity Testing Release Direct the accurate and timely testing of all materials Raw In-Process Finished Product Stability and authorize the release or rejection of products based on analytical results Investigations Oversee and approve all QC investigations including Out-of-Specification OOS Out-of-Trend OOT and deviation reports ensuring thorough root cause analysis and effective corrective and preventive actions CAPA Method Life Cycle Management Direct the development validation transfer and routine monitoring of analytical test methods to ensure they are phase-appropriate and robust Data Integrity Champion data integrity practices within the QC laboratory ensuring all electronic and paper records are accurate complete and attributable 12 Cross-functional Collaboration Internal Partnering Collaborate closely with Manufacturing Quality Assurance QA Regulatory Affairs and Research Development R D to resolve quality issues support process improvements and meet production deadlines Supplier Quality Coordinate with QA to evaluate and monitor the quality of materials received from suppliers Qualifications Education Bachelor s or Master s degree in Analytical Chemistry Organic Chemistry Experience 8-10 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 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 To Apply Interested candidates are invited to submit their resume and cover letter to n anjali celogenpharma com Job Type Full-time Pay 35 000 00 - 60 000 00 per month Work Location In person Expected Start Date 15 07 2025