KEY RESPONSIBILITIES:

　　This position leads Inprocess Quality Assurance (IPQA) for Non-Sterile manufacturing block to ensure that all operational activities of Quality Assurance are followed to ensure the supply of high-quality, GMP-compliant drug products from the site.

　　Assure all-time readiness of site for regulatory agency inspections/internal audits and appropriate implementation of corrective actions regarding observations made by the agencies/internal audit teams

　　Proactively assess quality issues at the site and ensure compliance to regulatory requirements in manufacturing operations at the site and track quality metrics with site manufacturing and drive them down

　　Prioritizing and monitoring the activities of QA officers for accuracy and compliance

　　Planning and arranging for internal and external departmental support of quality assurance activities as directed in approved protocols, quality systems or procedures.

　　Appropriate implementation of corrective actions regarding observations made by the agencies/internal audit teams. Sustain substantial compliance with quality operations at the site

　　Responsible for identifying and investigating Data Integrity Observations and taking appropriate CAPA to avoid repeat observations

　　Responsible for ensuring market complaints, failures, and deviations are investigated and corrective and preventive actions are implemented as per set timelines.

　　Execution of training for QA officer and contract persons.

　　Release of Bulk product for further stage.

　　Release of product for commercial dispatch

　　Monitor the quality policies, standards, and procedures for computerized systems that are implemented/established and adhered to at the site.

　　Monitor the QMS (Deviations, Change Control, CAPA, etc.) are closed in a timely manner

　　We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.