Quality Assurance Executive

Job Description

Job Title: QA Executive – Commercial & Regulatory Support Department: Quality Assurance Experience: 2-3 years Location: Ahmedabad Reports to: Sr. Manager -Regulatory Affairs Job Purpose: To support Quality Assurance activities related to commercial and regulatory documentation, artwork, and coordination with Contract Manufacturing Organizations (CMOs), ensuring compliance with current regulatory requirements and internal quality standards. Key Responsibilities: Review & Finalization of Commercial/Registration Artwork: Ensure all artwork (labels, cartons, leaflets, etc.) complies with country specific requirements and registration documents before final approval for printing. Review of Commercial Certificate of Analysis (CoA): Verify commercial batch CoAs against approved specifications for accuracy and compliance prior to release. Artwork Updates: Update artwork in alignment with the most recently approved registration certificates, ensuring timely communication and documentation. Regulatory & Commercial Support: Assist the Commercial and Regulatory Affairs departments with QA-related support in day-to-day operations. Coordination with CMOs: Collaborate and communicate with various Contract Manufacturing Organizations (CMOs) to facilitate commercial manufacturing activities and ensure quality compliance. Tender Document Preparation: Assist in the arrangement and compilation of QA-related documentation required for tenders and regulatory submissions. Required Experience & Skills: Minimum 2 years of experience in a QA role, preferably in pharmaceutical manufacturing or a regulatory environment. Familiarity with commercial product lifecycle documentation and regulatory compliance. Strong understanding of artwork control, CoA verification, and regulatory documentation. Good communication and coordination skills, especially with cross-functional teams and external stakeholders like CMOs. Detail-oriented with strong organizational and documentation skills. Educational Qualification: Master’s degree in pharmacy (M.Pharm) is mandatory. To Apply: Interested candidates can send their resume to hr@advanovpharma.com or contact us at 9974848421 .