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Senior Quality Control Specialist

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Baddi, Himachal Pradesh, India beBeeRegulatory Full time US$ 1,20,000 - US$ 1,75,000
Job Title: Senior Quality Control Specialist">

As a seasoned professional, you will play a pivotal role in ensuring the quality and compliance of our products. Your responsibilities will include:

  • Timely management of all QC documentation, including Change Controls, SOPs, Raw Data Sheets, GTPs, STPs, and Specifications, in alignment with regulatory guidelines.
  • Leading preparation, review, and approval of SAP specifications to ensure accurate material and test parameter alignment with regulatory and internal standards.
  • Evaluation, feasibility analysis, and risk assessment of pharmacopeial updates, ensuring seamless integration into QC systems and documentation.
  • Conducting impact assessments of new and revised regulatory guidelines, ensuring proactive updates to QC practices and documentation.
  • Evaluating and implementing QRI actions within defined timelines, ensuring risk analysis and implementation of actions identified.
  • Overseeing analytical method validation and verification activities in compliance with ICH, USP, and internal standards, ensuring robustness and regulatory readiness.
  • Managing QC-related activities for new product introductions and technology transfers, ensuring analytical readiness, method transfer, and documentation compliance.
  • Preparing and timely closure of audit responses for internal and external audits, ensuring adherence to commitments and continuous audit readiness.
  • Championing continuous improvement initiatives such as Lean Lab, Opti-Q, and method optimization to enhance efficiency, reduce waste, and improve data integrity.
  • Reviewing and approving analytical reports to ensure accuracy, completeness, and compliance with regulatory and internal quality standards.

Responsibilities also include coordinating laboratory training activities through ISOTrain, maintaining up-to-date training matrices and records.