Manager QC

Abbott Laboratories

0 years

4 - 5 Lacs

Baddi

Posted:2 days ago| Platform: GlassDoor logo

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Skills Required

qc management controls data sap test drive evaluation analysis risk assessment integration verification compliance technology documentation audit audits lean optimization efficiency reports training

Work Mode

On-site

Job Type

Part Time

Job Description

The Job Responsibilities of the position holder include :

Ensure timely and compliant management of all QC documentation—including Change Controls, SOPs, Raw Data Sheets, GTPs, STPs, and Specifications—in alignment with Abbott AQD/EQD and applicable regulatory guidelines.
Lead the preparation, review, and approval of SAP specifications to ensure accurate material and test parameter alignment with regulatory and internal standards.
Drive timely 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, ensuring proactive updates to QC practices and documentation.
Evaluate and implement QRI actions within defined timelines, ensuring risk analysis and implementation of actions identified.
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.
Lead preparation and timely closure of audit responses for internal and external audits, ensuring adherence to commitments and continuous audit readiness.
Champion continuous improvement initiatives such as Lean Lab, Opti-Q, and method optimization to enhance efficiency, reduce waste, and improve data integrity.
Review and approve analytical reports to ensure accuracy, completeness, and compliance with regulatory and internal quality standards.

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

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