Site Quality Head – OSD

Job Description

About the Company The company is a reputed and well-established name in the pharmaceutical manufacturing industry , operating a high-compliance Oral Solid Dosage (OSD) facility in Vapi, Gujarat . The plant adheres to stringent global quality and regulatory standards and supplies to both domestic and international markets. The organization is committed to delivering high-quality products through robust systems and a strong quality culture. Role Overview We are hiring for a Site Quality Head to lead and oversee the Quality Assurance and Quality Control functions at the OSD manufacturing plant in Vapi. The role involves full ownership of quality systems, lab operations, regulatory compliance, and audit readiness. The ideal candidate should be currently working as a site-level quality head , with hands-on experience managing both QA and QC teams in a regulated pharmaceutical environment. Key Responsibilities Lead and manage the complete Quality function (QA and QC) at the site Ensure compliance with GMP, regulatory, and customer requirements Oversee quality systems , including deviations, CAPAs, change controls, validations, and documentation Monitor and guide all laboratory operations , including chemical, instrumentation, and microbiological testing Prepare for and lead regulatory and customer audits (USFDA, MHRA, WHO-GMP, etc.) Drive continuous improvement in quality processes and systems Collaborate cross-functionally with production, supply chain, engineering, and regulatory teams Develop and mentor the site’s QA and QC teams, fostering a strong quality culture Key Requirements B.Pharm / M.Pharm / M.Sc or equivalent in life sciences Minimum 15 years of experience in the pharmaceutical industry, with significant exposure to OSD manufacturing Must be currently working as a Site Quality Head or in an equivalent leadership role Proven experience managing both Quality Assurance and Quality Control functions In-depth knowledge of GMP regulations , audit readiness, and global regulatory expectations Strong leadership, communication, and stakeholder management skills Experience in handling regulatory inspections and third-party audits