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Amneal

Senior Executive, Lab QA

Amneal Ahmedabad, Gujarat, India

Pharmaceutical Manufacturing · 5,001-10,000 employees

14 h ago
qa Senior (5-10 yrs) Full-time India
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About the role

Responsible for the review and approval of analytical data, laboratory documentation, and quality system records to ensure compliance with cGMP and GLP standards. Oversees method validation, instrument qualification, stability protocols, and investigations to maintain data integrity.

What they look for

Quality Assurance Laboratory Documentation Analytical Data Review cGMP Compliance GLP Compliance Data Integrity ALCOA Principles LIMS Instrument Calibration Method Validation Method Transfer Stability Testing Audit Trail Review Investigation Management Vendor Qualification Computer System Validation

Requirements

Requires a Bachelor's or Master's degree in Pharmacy with 5 to 8 years of relevant experience in a laboratory quality assurance role. Candidates must possess strong knowledge of regulatory compliance, documentation practices, and analytical laboratory systems.

Full description

  • Review analytical data for Raw Materials (RM), Packaging Materials (PM), in-process samples, Finished Products (FP), stability samples, working standards, reference standards, and other test samples.
  • Review and approve Certificates of Analysis (COAs) for RM, PM, in-process samples, FP, stability working standards, reference standards, and other test samples.

samples.

  • Review SOPs, STPs, specifications, and other laboratory documents.
  • Verify the accuracy of data entered in LIMS and manual documentation systems.
  • Review protocols and reports related to analytical method transfer, validation, verification, and waiver activities. Review analytical raw data associated with method transfer, validation, and verification studies.
  • Review and approve daily verification, calibration, and qualification records of laboratory instruments and equipment.
  • Review and approve Computer System Validation (CSV) documents.
  • Review instrument logbooks, calibration records, and third-party calibration reports.
  • Review and approve the audit trail reports for Empower and non-CDS systems.
  • Review stability schedules, stability protocols and stability reports.
  • Ensure data integrity and compliance with ALCOA principles and documentation practices. Verify analytical records for compliance with GLP and cGMP requirements.
  • Review investigations related raw data and report i.e. OOS, OOAL/OOT, deviations, incidents, and change controls.
  • Review vendor qualification reports and related documentation.
  • Review reduced testing reports and related documentation.
  • Review analytical data and COAs received from contract testing laboratories.
  • Review and approve preparation records of reagents, mobile phases, diluents, impurity solutions, and other laboratory solutions.
  • Review analytical raw data for analyst qualification and approved.
  • Verify compliance of laboratory activities through documentation review.

Additional Responsibilities:

Qualifications

Education:• B. Pharm B. Pharm - Required

  • M. Pharm M. Pharm - Preferred

Experience:• 5 years or more in 5 - 8 Years

Specialized Knowledge: Licenses:

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