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Job Description: Head of Quality Experience: 15 Years or more Location: Udaipur About Macsen Drugs: Macsen Drugs is a USFDA registered, WHO-GMP certified, TGA GMP certified, and EU GMP (Written Confirmation) certified manufacturer of active pharmaceutical ingredients or bulk drugs for varied therapeutic applications like antidote, urinary antiseptic, topical antiseptic, ophthalmic diagnostic, anti-dandruff, anti-acne, and several other applications. Job Overview: We are seeking an experienced and detail-oriented individual to perform research activities as designing and conducting scientific experiments, analyzing and interpreting results, leading to significant value to the process development. Efficient contribution to the overall success of the research & development team performance according to objectives and targets set by the Management. Responsibilities: 1. Quality Assurance (QA) Develop and implement a comprehensive Quality Management System (QMS) compliant with cGMP and ICH guidelines. Review and approve quality documents such as SOPs, batch records, deviations, and CAPA reports. Ensure the site is prepared for regulatory audits and inspections from the USFDA, EMA, WHO, and other agencies. Conduct internal audits and self-inspections to maintain quality standards. 2. Quality Control (QC) Oversee laboratory operations, ensuring raw materials, intermediates, and finished products meet established quality specifications. Manage analytical method validations and stability studies. Monitor calibration and maintenance of laboratory instruments. 3. Regulatory Affairs Prepare and submit regulatory documents, including DMFs, for US and international markets. Address regulatory queries and implement corrective actions for observations from audits or inspections. Stay updated on global regulatory trends and ensure compliance with evolving requirements. 4. Production Oversight Collaborate with production teams to ensure manufacturing processes align with quality standards. Oversee cleaning and process validation for a multi-product facility to prevent cross-contamination. Troubleshoot production and analytical challenges in coordination with R&D. 5. Data Integrity and Security Ensure compliance with 21 CFR Part 11 for electronic records, signatures, and data integrity. Establish protocols for data security and governance across all quality operations. 6. Cross-Functional Coordination Work with R&D and Analytical Development Labs for seamless technology transfer and method development. Collaborate with Stores and Maintenance teams to ensure proper inventory management and equipment validation. Coordinate training programs for team members to maintain high-quality standards. 7. Leadership Lead and mentor teams across QA, QC, Regulatory, Production, and Maintenance departments. • Foster a culture of quality, accountability, and continuous improvement. 1. Educational Qualifications Bachelor's or Master's degree in Pharmacy, Chemistry, Biotechnology, or a related scientific field. Additional certifications in Quality Management Systems (e.g., ISO 9001, Six Sigma) are preferred. 2. Experience Requirements Minimum 15 years of experience in API manufacturing, with at least 5 years in a leadership role managing QA, QC, and Regulatory Affairs. Proven experience in handling audits and inspections by regulatory agencies such as USFDA, EMA, WHO, or PICS. Hands-on experience in managing multi-product facilities with cleaning and process validation expertise. How to Apply: Send your updated resume to hrd@macsenlab.com
