Job Summary
A leading pharmaceutical company in Baddi is seeking an experienced Director of Quality Assurance to lead and manage Quality Assurance (QA) and Quality Control (QC) functions across ODF, LVP, and Hormone blocks. This leadership role demands deep expertise in GMP compliance, regulatory inspections, quality risk management, and strategic process improvements. The ideal candidate will ensure the plant remains inspection-ready and aligned with Abbott’s global quality policies.
Key Responsibilities
Develop and implement QA/QC strategies ensuring smooth operations for ODF, LVP, and Hormone manufacturing units.
Plan continuous improvement initiatives in GMP, quality systems, and procedures.
Manage department budgeting, performance monitoring, and resource allocation.
Set and oversee KRAs for QA and QC teams, ensuring adherence to global standards.
Collaborate cross-functionally (Manufacturing, Engineering, Warehouse) to maintain regulatory readiness.
Ensure timely responses and CAPA implementations for corporate, customer, and regulatory audits.
Uphold and execute Abbott’s policies, procedures, and quality expectations at the site.
Lead self-inspections, internal audits, and drive enhancements in Pharmaceutical Quality Systems.
Supervise batch release processes according to internal and global guidelines.
Approve quality control processes, including material approvals/rejections and deviation handling.
Facilitate product recalls in coordination with regional quality teams.
Drive Quality Risk Management and communicate risks to senior leadership.
Implement and maintain GxP-compliant document control and laboratory practices.
Lead site training programs to enforce Good Manufacturing Practices (GMP) and documentation standards.
Required Skills & Qualifications
M.Sc / B.Pharm / M.Pharm / Ph.D in Pharmacy or related discipline.
Minimum 15 years of relevant experience in Quality Assurance in a pharmaceutical formulation plant.
Proven leadership in handling USFDA, EU GMP, and other global regulatory audits.
Expertise in GMP, QMS, risk management, and pharmaceutical manufacturing processes.
Strong knowledge of GxP, GLP, and Good Documentation Practices.
Excellent communication, leadership, and problem-solving skills.
Perks & Benefits
Competitive salary package (Not specified in JD).
Leadership opportunity in a globally recognized pharmaceutical company.
Exposure to international regulatory frameworks and best practices.
Professional development in a quality-driven and innovation-focused environment.
Company Description
A globally reputed pharmaceutical organization specializing in oral dosages, large volume parenterals, and hormone therapies. The company maintains world-class manufacturing practices adhering to USFDA, EU GMP, and NABL standards while driving continuous improvement and regulatory compliance.
Work Mode
On-site – Baddi, India
Call-to-Action
Are you a seasoned Quality Assurance leader ready to ensure world-class quality and compliance standards? Apply now to drive excellence in pharmaceutical manufacturing at our Baddi facility!
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