Job
Description
As a Site Quality Head at our reputed pharmaceutical manufacturing company in Vapi, Gujarat, you will be responsible for leading and overseeing the Quality Assurance and Quality Control functions at our Oral Solid Dosage (OSD) facility. Your role will involve full ownership of quality systems, lab operations, regulatory compliance, and audit readiness. To excel in this position, you should currently hold a site-level quality head role and have hands-on experience managing 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,
