Job Summary
Join a global pharmaceutical leader as Manager – Quality Control (QC) based in Baddi, India. This strategic role is responsible for overseeing all QC documentation, audit preparedness, analytical validation, and regulatory compliance aligned with global standards such as ICH, USP, and Abbott EQD. Ideal for professionals with strong expertise in pharmaceutical quality systems and a passion for continuous improvement.
Key Responsibilities
Manage QC documentation including Change Controls, SOPs, Raw Data Sheets, GTPs, STPs, and Specifications per regulatory standards.
Review and approve SAP specifications to ensure data accuracy and compliance.
Conduct feasibility and risk assessments for pharmacopoeial and regulatory updates.
Ensure robust implementation of QRI actions with timely follow-through.
Oversee analytical method validation and verification in alignment with ICH and USP.
Support new product introductions and technology transfers from a QC perspective.
Lead preparation and closure of audit responses for internal/external audits.
Drive continuous improvement initiatives like Lean Lab and Opti-Q.
Approve analytical reports ensuring regulatory and internal compliance.
Maintain laboratory training compliance via ISOTrain and manage training matrices.
Required Skills & Qualifications
Strong understanding of QC documentation systems and regulatory frameworks.
Experience with SAP specifications and material/test parameter configuration.
Proficient in ICH, USP guidelines, and analytical method validation.
Hands-on experience with pharmacopoeial updates and impact assessments.
Audit management experience (internal, external, regulatory).
Familiarity with Lean Lab, Opti-Q, and continuous improvement tools.
Excellent documentation, communication, and cross-functional coordination skills.
Working knowledge of ISOTrain and training compliance systems.
Perks & Benefits
Competitive compensation and performance bonuses
Structured training and development programs
Opportunity to work with global quality and compliance leaders
Exposure to new technologies and pharmaceutical innovations
Inclusive work culture and growth-focused environment
Company Description
Abbott is a global healthcare company recognized for its commitment to advancing medical science, diagnostics, and pharmaceuticals. With world-class manufacturing operations in India, Abbott delivers quality-driven products aligned with global standards, driving better health outcomes across markets.
Work Mode: On-site (Baddi, India)
Call to Action
If you have a passion for pharmaceutical quality control and compliance, and you're ready to lead critical QC operations at a global healthcare organization, apply now to join Abbott in Baddi and make a measurable impact on product quality and patient safety.
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