QA Analyst

3 months ago

Sany, India Acme Services Private Limited Full time
KeyResponsibilities The QA Analyst will be responsible for ensuring thequality and compliance of pharmaceutical products through variousstages of manufacturing testing and distribution. This roleinvolves implementing and maintaining quality systems conductingaudits and providing support for regulatory inspections.
Review and approve documents related to manufacturing packaginglabeling and testing to ensure compliance with regulatory standards(e.g. FDA EMA).
Conduct batch record review and releaseactivities in accordance with standard operating procedures(SOPs).
Monitor and evaluate manufacturing processes toidentify and address quality issues and deviations.
Implement and maintain quality management systems includingdocument control change control and CAPA (Corrective and PreventiveAction) systems.
Develop and update SOPs protocols andother qualityrelated documents as needed.
Facilitatetraining programs to ensure staff compliance with quality standardsand procedures.
Conduct internal audits to assesscompliance with GMP (Good Manufacturing Practices) and otherregulatory requirements.
Coordinate external audits andinspections by regulatory agencies and customers.
Collaborate with crossfunctional teams to address audit findingsand implement corrective actions.
Identify opportunitiesfor continuous improvement in quality processes andsystems.
Participate in quality risk assessments anddevelop risk mitigation strategies.
Support validationactivities for equipment processes and analyticalmethods.

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