Vice President

Job Description : Vice President Quality & Regulatory - API INDIA Responsibilities: • Quality Management, QMS Activities - Batch Release, investigations, CAPA Implementation, Change Controls, Market Complaints, laboratory Controls, Risk Assessments. • Maintains Comprehensive Knowledge of Applicable Regulatory Requirements & their Interpretation. • Provides Regulatory Compliance Expertise to the Site Management by Sharing information about the External Regulatory Environment, Industry Trends, as well recommending Actions to Address any Potential Impact. • Identify & Communicate Systemic Issues to for further Comprehensive Action. • Directs the Internal Auditing Function & the Audit Team Members for the Implementation of Regulatory & Quality System Effectiveness Audits. • Coordinates, Conducts, & Manages Routine & Directed Audits FDA, Notified Body, Regulatory Agency) as needed to Assure Compliance with Domestic and International Regulations. • Regulatory Responses, Remediation Plans, Global Reviews. • Responsible for Monitoring the Timely Completion of Corrective Action Plans and to Coordinate the Reporting of Compliance Metrics during Management Reviews. Qualifications & Exp.: • Post Graduate in Pharma / Ph.D. (Pharma / Organic Chemistry). • Should have about 20 Years of Exp. in a Pharma Organisation. • Strong interpersonal skills. Skills & Expertise: • A Visionary leader with Tremendous Drive, Energy & Passion to lead the function. The Person Should bring a Problem Solving Mindset & is Solutions Oriented. • Good Regulatory Knowledge of Markets like Europe, Australia, Japan, Brazil, US, Canada etc.Skills Required will Include Strong written Communication, Strong Verbal Communication, Organisation Skills, Prioritising, & Multitasking.

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