Instagram
youtube
Facebook

Manager Qc

0-2 years
Not Disclosed
10 Sept. 8, 2025
Job Description
Job Type: Full Time Education: B.Sc/ M.Sc/ M.Pharm/ B.Pharm/ Life Sciences 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

Key Responsibilities

1. Documentation & Compliance

  • Ensure timely and compliant management of all QC documentation, including Change Controls, SOPs, Raw Data Sheets, GTPs, STPs, and Specifications, in line with Abbott AQD/EQD and applicable regulatory requirements.

  • Lead the preparation, review, and approval of SAP specifications to ensure accurate material and test parameter alignment with regulatory and internal quality standards.

2. Regulatory & Pharmacopeial Updates

  • Drive evaluation, feasibility analysis, and risk assessment of pharmacopeial updates, ensuring seamless integration into QC systems and documentation.

  • Conduct impact assessments of new and revised regulatory guidelines, proactively updating QC practices and documentation to remain compliant.

3. Quality Risk & Improvement (QRI) Actions

  • Evaluate and implement QRI actions within defined timelines, including risk analysis and execution of required actions.

4. Analytical Method Management

  • Oversee analytical method validation and verification activities in compliance with ICH, USP, and internal standards, ensuring robustness and regulatory readiness.

  • Manage QC-related activities for new product introductions and technology transfers, ensuring analytical readiness, method transfer, and documentation compliance.

5. Audit & Inspection Readiness

  • Lead the preparation and timely closure of audit responses for internal and external audits, ensuring commitments are met and continuous audit readiness is maintained.

6. Continuous Improvement

  • Champion initiatives such as Lean Lab, Opti-Q, and method optimization to enhance efficiency, reduce waste, and strengthen data integrity.

7. Analytical Review & Reporting

  • Review and approve analytical reports for accuracy, completeness, and compliance with regulatory and internal quality standards.

8. Training & Development

  • Ensure laboratory training compliance by coordinating activities through ISOTrain and maintaining up-to-date training matrices and records.