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Team Member - Quality Control

Team Member - Quality Control

ConfidentialHyderabad / Secunderabad, Telangana, India
4 days ago
Job description

Job Description

  • To ensure timely and thorough investigation of quality-related events such as deviations, OOS, and OOT results in compliance with regulatory standards and internal SOPs, thereby maintaining product quality and patient safety.
  • Deviation Handling :

Initiate and lead investigations for laboratory and manufacturing deviations.

  • Identify root causes using tools like 5 Whys, Fishbone, or CAPA analysis.
  • Collaborate with cross-functional teams to implement corrective and preventive actions (CAPA).
  • OOS Investigations :

    • Conduct Phase I and Phase II investigations for OOS results.

  • Review analytical data, equipment logs, and analyst performance.
  • Coordinate retesting and reanalysis as per SOPs.
  • Document findings and ensure regulatory compliance (e.g., MHRA, FDA).
  • OOT Investigations :

    • Monitor data trends and identify atypical results.

  • Investigate potential causes for OOT results and assess batch impact.
  • Recommend actions to prevent recurrence.
  • Documentation & Reporting :

    • Prepare detailed investigation reports with evidence and conclusions.

  • Maintain records in compliance with Good Documentation Practices (GDP).
  • Present findings during audits and regulatory inspections.
  • Compliance & Training :

    • Ensure investigations align with cGMP, ICH and regulatory expectations.

  • Train QC analysts on investigation procedures and data integrity.

    • Qualifications

    M.SC / B.Pharma

    3 to 10 years

    Skills Required

    Cgmp, fishbone , Ich

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    Quality Control • Hyderabad / Secunderabad, Telangana, India