Job Summary
We are seeking an experienced Head of Quality Control for our pharmaceutical manufacturing site in Baddi, India. This leadership role requires an expert in quality control laboratory operations, GxP compliance, and regulatory audit readiness, including USFDA and EU GMP inspections. The ideal candidate will drive laboratory quality systems for oral dosage forms and large volume parenterals (LVP), ensuring excellence in testing, validation, documentation, and continuous improvement.
Key Responsibilities
Develop, implement, and maintain GxP-compliant laboratory systems and procedures.
Ensure effective training and adherence to Good Laboratory Practices (GLP).
Oversee analysis, approval/rejection of starting materials, packaging, intermediates, bulk, and finished products for oral dosages and LVPs.
Approve specifications, sampling instructions, testing methods, and QC procedures.
Ensure execution of method validations, calibrations, and equipment maintenance.
Lead stability studies and ensure testing meets current pharmacopoeial standards.
Review and approve contract analysis activities and ensure regulatory compliance.
Conduct laboratory investigations, risk assessments, and CAPA implementation.
Monitor QC progress, report discrepancies, and provide improvement recommendations.
Manage laboratory Quality Management System (QMS) and internal audits (NABL ISO/IEC 17025).
Support regulatory inspections (e.g., USFDA, EU GMP) and internal continuous improvement initiatives.
Design and deliver QC training programs; ensure ISOtrain compliance.
Act as Business Administrator for the Darius system to control document workflows.
Required Skills & Qualifications
M.Sc / B.Pharm / M.Pharm / Ph.D in Pharmacy or related discipline.
Minimum 15 years of relevant experience in pharmaceutical QC functions at a formulation plant.
Proven expertise in managing USFDA, EU GMP, and other regulatory audits independently.
In-depth knowledge of GLP, GMP, QC procedures, and analytical validations.
Experience with NABL ISO/IEC 17025 laboratory management systems.
Strong leadership, problem-solving, and cross-functional coordination skills.
Perks & Benefits
Attractive compensation package (Not disclosed in JD).
Leadership role in a globally recognized pharmaceutical facility.
Direct involvement in international regulatory inspections and global quality systems.
Opportunities for professional development and strategic contribution to organizational goals.
Company Description
A reputed pharmaceutical organization specializing in the development and manufacture of high-quality oral and injectable products. The company is committed to regulatory excellence, innovation, and maintaining global quality standards including USFDA, EU GMP, and NABL certifications.
Work Mode
On-site – Baddi, India
Call-to-Action
Are you an experienced Quality Control leader ready to take charge of laboratory excellence and regulatory compliance? Apply now to join our high-performing pharmaceutical quality team in Baddi!
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