AGM - Quality Assurance

1 month ago

Ahmedabad, India Intas Pharmaceuticals Full time

Roles and Responsibilities:

  • Person shall have through knowledge of various guidelines pertaining to cGMP and GLP specifically EU GMP, MHRA, USFDA and shall be aware with ICH guidelines of quality.
  • Shall have through understanding of quality management procedures like change controls, deviations, CAPA, recall, market complaint, self-inspections etc.
  • Shall have knowledge of investigation of Out of specification (OOS), Out of trend (OOT) results, lab incidents and have skills to collaborate with cross-functional teams to address root cause of quality issues.
  • Person shall have knowledge of Analytical method validation (AMV), analytical method transfers (AMT) and compendial method verification procedures.
  • Shall be able to review / approve AMV/AMT protocols and reports, perform / review gap assessment and to assist in analytical activities for smooth execution.
  • Shall be able to Identify and assess potential quality risks and develop risk mitigation strategies.
  • Shall be aware with various laboratory management software which includes but not limited to LIMS (Laboratory Information Management System), Chromaleone software, Empower application software, stability management software etc.
  • Shall possess experience to review electronic data and audit trail of various applicable instruments but not limited to HPLC, GC, UV, IR etc.
  • Shall have knowledge of various documents for specifications, test data sheets / analytical reports and SOPs as applicable.
  • Shall be aware with data integrity and its principles.
  • Shall have sound knowledge on mfg processes for Solid oral as well as injectable products
  • Shall have knowledge for QA batch release processes for Europe/UK and MENA region
  • Shall have knowledge on various EU/MHRA guidelines for importation / batch release and annex XVI requirements.
  • Should lead the OOS / OOT / Failure investigation


Core Competency skills:

  • Strong technical knowledge of analytical methods, quality testing procedures and instrumentations.
  • Excellent communication and collaboration skills with cross functional team / clients / labs / service provider etc.
  • Demonstrated ability to identify and solve problems related to quality. Statistical
  • Time Management - uses time effectively and efficiently; concentrates efforts on the more important priorities.
  • Team leader and provide mentoring on various technical subject to team / should lead batch release team

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