DGM- Corporate Quality Audit

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.

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).