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Manager Qc

8-12 years
Not Disclosed
10 July 28, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

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.