Job Purpose: Effectively execute the action items for the observations from internal audits, financial audits, regulatory audits of Cipla, regulatory audits of other companies etc., across Cipla.Daily Monitoring of life cycle management of observations, action items, implementation of CAPA and sustenance of CAPA across Cipla.Escalate risks arising out of compliance to top management in timely manner. Accountability ClusterMajor Activities / Tasks I. Improve the system and process for implementation of Quality compliance across Cipla sites. Identify the gaps in Quality compliance implementation process and continuously improve the system. Process to receive the inputs ( internal audits, financial audits, regulatory audits etc.,) disseminate across cipla units, effective implementation of action items, monitoring of action items and ensure sustenance of previously implemented action items II. Coordination and vigilant monitoring Vigilant monitoring of action items, CAPA across sites Coordinate with Site QA heads on timely and effective implementation of action items Coordinate with internal audit team, regulatory surveillance team on daily basis on 483s of other companies, internal audit observations etc., Coordinate with CFT members on Quality compliance . III. Appraise top management on Quality compliance Appraise top management on daily basis on risk of quality compliance. Escalate to top management on critical issues in timely manne InternalExternal Internal audit team on internal audit observations Regulatory intelligence team on other companies 483s and new regulations and guidance Site QAs for effective implementation of actions Site Heads for effective implementation of actions CQA SOP team for QA and QC SOP team Vendors through vendor quality team and SCM on Quality compliance. Cipla USA and its US Affiliates is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, sex, sexual orientation, gender identity, religion, national origin, genetic information, disability, or protected veteran status.
