Job Title: Director – Quality Assurance
Location: Baddi, Himachal Pradesh, India
Company: Abbott
Work Mode: On-site
Experience Required: 15+ years in Quality Assurance within pharmaceutical manufacturing
Salary Range: Not specified
Job Summary
Abbott is seeking an experienced Director of Quality Assurance to lead and strategize QA & QC functions at its pharmaceutical manufacturing site in Baddi, India. The role encompasses oversight of oral dosage forms (ODF), large volume parenterals (LVP), and hormone block operations, ensuring adherence to GMP, GXP, and regulatory standards. The position plays a crucial leadership role in maintaining audit readiness, driving continuous improvement, and ensuring product quality across departments.
Key Responsibilities
Strategize QA/QC operations for ODF, LVP & Hormone block for optimal compliance and efficiency.
Lead GMP and regulatory compliance initiatives for systems, documentation, and facilities.
Oversee budgeting and performance monitoring against CAPEX and OPEX.
Lead internal and external audits; ensure timely CAPA implementation.
Implement and manage Abbott Policies and QA procedures across the site.
Oversee submission and compliance of regulatory filings and documents.
Ensure site readiness for regulatory and customer inspections.
Maintain quality risk management strategies aligned with patient safety.
Guide training, GMP documentation, and process improvement efforts.
Manage batch release, material approvals, and product recalls as per regulations.
Required Skills & Qualifications
Bachelor's or Master’s degree in Pharmacy, Life Sciences, or related field.
15+ years of pharmaceutical QA experience; 5+ years in a leadership role.
Deep understanding of GMP, GXP, ICH, WHO, and FDA standards.
Hands-on expertise in audits, CAPA, change controls, deviations, and documentation.
Proven ability to manage multidisciplinary QA/QC functions at manufacturing sites.
Experience with regulatory submissions and compliance (India and international).
Strong leadership, team management, and communication skills.
Exposure to cybersecurity, digital QA tools, and document control systems.
Perks & Benefits
Leadership role in a globally respected pharmaceutical company.
Structured career advancement within Abbott's global QA network.
Exposure to diverse dosage forms including hormone and LVP.
Industry-best systems, processes, and audit practices.
Competitive salary package and performance-based incentives.
Comprehensive health and wellness programs.
Professional development and training support.
Company Description
Abbott is a global healthcare leader with over 130 years of innovation in pharmaceuticals, diagnostics, and medical devices. In India, Abbott's manufacturing and R&D facilities are aligned with international regulatory standards, making it a trusted name in healthcare quality and safety.
Work Mode
On-site – Baddi, Himachal Pradesh, India
Call to Action
If you're a seasoned quality professional ready to lead with impact, apply now for the Director – Quality Assurance role and shape the future of pharmaceutical manufacturing with Abbott.
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