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Job Title DGM - Corporate Quality Audit Business Unit Global Quality Compliance Job Grade G8 Location Mumbai At Sun Pharma we commit to helping you Create your own sunshine - by fostering an environment where you grow at every step take charge of your journey and thrive in a supportive community Are You Ready to Create Your Own Sunshine As you enter the Sun Pharma world you ll find yourself becoming Better every day through continuous progress Exhibit self-drive as you Take charge and lead with confidence Additionally demonstrate a collaborative spirit knowing that we Thrive together and support each other s journeys Job Summary To manage quality audit of vendors supplying API s Intermediate Key raw materials excipients and other raw materials etc in compliance with applicable regulations and company policies standards procedures To qualify vendors supplying raw and packaging materials To ensure correctness and completeness of all vendor audit related documents Provide necessary guidance to the team members for handling activities w r t the life cycle management of vendors To support sites in regulatory inspections and related compliance as required Key responsibilities Manage quality audit program for vendors supplying APIs Intermediates Key raw materials excipients and other raw materials etc To prepare periodic audit schedule plan for Asia EU and US region vendors in coordination with commercial supply chain department To allot scheduled vendor audits to the auditors and ensure execution of audits as per schedule and applicable regulatory requirements company policies and standards To ensure preparation of audit reports and its distribution to the vendors within defined timeline To coordinate with commercial department for timely receipt of compliance response from audited vendors To ensure that responses are reviewed and audits are closed within defined timeline To conduct vendor qualification audits and escalate key learnings of vendor audit to the reporting manager HOD To handle review vendors with regulatory enforcement like warning letters import alerts Non-conformance reports To ensure that For-cause audits are executed on need basis To ensure initiation of de-registration process for vendors with critical GMP non-conformances during audits To ensure execution of re-audits for conditionally approved vendors and for CAPA verification at vendor site To check the adequacy of audit reports and guide team members for the same To approve Quality Technical Agreements with vendors as applicable To approve extension for audits that are not completed as per schedule To provide technical support to the cross functional teams as and when required To prepare approve departmental global standards procedures To set implement KPI s and check effectiveness of audit program To qualify vendors supplying raw and packaging materials to the Sun manufacturing sites and to manage activities and resources necessary to support functioning of vendor office management To review Annual Risk Assessment received from different sites of Sun pharma To suggest appropriate CAPA and support in compliance of manufacturing sites audits To monitor monthly audit and response status To prepare monthly report and submit to HOD To review assess gaps in procedure practices system in line with regulatory requirement and fix it as a part of continuous improvement To identify training needs of team members and ensure compliance to training plans To conduct CMO audits and corporate quality audits at the manufacturing sites of Sun Pharma as required To participate assist in any other activity allocated by reporting manager Travel Estimate Job Requirements Educational Qualification M Pharm Experience Tenure 24 Years of total experience in various functions of quality in reputed organizations Initial 10 years of work experience in formulation manufacturing OSD OLD Cream ointment lotions and rest 13 years in various sections of corporate quality assurance Having strong knowledge of GMPs in both domestic and regulatory environment Successfully faced regulatory inspections like USFDA MHRA TGA INVISA INVIMA WHO Geneva TPD etc Worked in lead role in the areas like Harmonization of QMS Audit compliance Vendor Management Investigation Manufacturing Assurance Qualification and Validations Having good interpersonal organizational and communication skills Approved chemist in chemical and instrumental analysis Your Success Matters to Us At Sun Pharma your success and well-being are our top priorities We provide robust benefits and opportunities to foster personal and professional growth Join us at Sun Pharma where every day is an opportunity to grow collaborate and make a lasting impact Let s create a brighter future together Disclaimer The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification It is not designed to contain or be interpreted as a comprehensive inventory of all duties responsibilities and qualifications required of employees as assigned to this job Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent s