Qa Head

3 weeks ago

Nalagarh HP IN Elfin Pharma Full time

Head of Quality Assurance Pharma Position Head - Quality Assurance QA Department Quality Assurance Reports To Managing Director Plant Head VP - Quality Location Nalagrah HP Role Summary The Head of Quality Assurance is responsible for leading the QA function to ensure that all pharmaceutical products are manufactured in compliance with cGMP regulatory guidelines USFDA EMA MHRA WHO CDSCO etc and company quality standards This role oversees quality systems documentation audits training compliance and continuous improvement initiatives to maintain a state of inspection readiness at all times Key Responsibilities Quality Systems Compliance Establish implement and monitor Quality Management Systems QMS in line with global regulatory requirements Ensure compliance with ICH WHO USFDA EMA MHRA CDSCO and other regulatory guidelines Oversee change control deviations CAPA OOS OOT risk management and product quality reviews Documentation Records Approve SOPs Batch Manufacturing Records BMRs Batch Packaging Records BPRs and quality policies Maintain data integrity and electronic documentation compliance Audits Inspections Prepare the site for regulatory and customer audits inspections Lead internal audits and vendor audits ensure timely closure of audit findings Team Leadership Training Lead and mentor the QA team ensuring continuous training on GMP and quality standards Foster a culture of compliance integrity and continuous improvement Product Quality Release Ensure timely review and approval of batch manufacturing and analytical documents Authorize batch disposition release in compliance with regulatory requirements Cross-functional Collaboration Work closely with Production QC R D Supply Chain and Regulatory Affairs teams Provide QA support for technology transfer validation and new product launches Continuous Improvement Risk Management Drive initiatives for operational excellence and quality improvements Implement Quality by Design QbD and risk-based approaches in manufacturing Qualifications Experience Education M Pharm B Pharm M Sc Chemistry Biotechnology Microbiology Experience Minimum 15 years in Quality Assurance Quality Control in the pharmaceutical industry with at least 5 years in a leadership role Strong knowledge of global regulatory requirements USFDA EU MHRA WHO TGA CDSCO etc Proven experience in handling regulatory inspections and audits Excellent leadership communication and decision-making skills Key Competencies Strong understanding of cGMP GLP GDP Leadership and people management Analytical thinking and problem-solving Strategic planning and execution Inspection readiness and compliance mindset Job Type Full-time Pay 80 000 00 - 90 000 00 per year Benefits Food provided Health insurance Provident Fund Work Location In person Speak with the employer 91 7657867748

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