Sr. Executive NAM Quality Cluster

Job Title

Sr. Executive NAM Quality Cluster

Business Unit

Global Quality & Compliance

Job Grade

Sr.Executive

Location :

Baroda

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.

Key Responsibilities

This position shall be responsible for,

• Oversee life cycle of customers, vendors and contract service providers (CSP) for NAM Cluster site
• Prepare, review and maintain quality agreements with customers, vendors and contract service providers.
• Ensure responsibilities between company and other party are clearly defined.
• Work collaboratively with Corporate Quality, Vendor Office Management and Site Quality to support qualification and approval of identified vendor and CSP and for periodic surveillance or for-cause audit of vendor or CSP
• Coordinate for vendor registration, documents review, risk assessment, technical evaluation and quality evaluation.
• Ensure all contract service providers are evaluated for capability, compliance and suitability before approval.
• Ensure all outsourced activities are clearly defined, controlled and documented.
• Ensure service providers comply with applicable GMP, GDP, data integrity and company requirements.
• Ensure CSP possess required State Licenses, Debarment certification and GMP accreditation, as applicable
• Review service provider performance at defined intervals.
• Work as a point of contact between Corporate Quality, Vendor Management Office and Site Quality teams for overall management of Vendors, Customers and Contract Service Providers.
• Coordinate for vendor registration, documentation review, risk assessment, technical evaluation, quality evaluation and status update in the electronic/manual system after completion of approved qualification requirements.
• Maintain and distribute the Approved Vendor List where manually maintained and ensure vendor qualification documents and status are current and traceable.
• Coordinate with VOM/CQA for onsite, remote or document-based audits through Audit Request Forms. Track audit requirements for qualification and re-qualification of Vendors/CSPs/CMOs as applicable.
• Prepare/compile risk assessments for conditionally approved vendors and regulatory restrictions. Perform annual vendor risk assessment.
• Conduct risk assessment for contractors discontinued due to quality/regulatory concerns and CSPs managed at site level.
• Support in evaluation of new CMOs/CSPs and work with Procurement, Global Supply Chain, Site QA and User departments to define selection criteria and quality expectations.
• Develop and maintain metrics for CSP/vendor monitoring and re-evaluation, including quality risk assessment, service performance, audit status and documentation compliance.
• Initiate Vendor Suspension / Discontinuation / Re-activation proposal, when required.
• Initiate the audit request for qualification/re-qualification of CSPs used by the site and managed at the corporate level.
• Prepare Quality Agreements, assist/lead negotiation with vendors/contractors as applicable.
• Ensure review and approval of Quality Agreements before activity initiation and manage lifecycle of Quality Agreements i.e., retention, renewal and retrieval of Quality Agreements.
• Ensure availability of vendor technical/quality documents and Quality Agreement through electronic/manual systems.
• Support in new material code creation for ZLAB items in MDO Fuse portal for Quality, as needed.
• Any additional work assigned by the reporting manager to support North America Cluster.
  
  

Travel Estimate

As required by Business

Job Requirements

Educational Qualification

B.Pharm / M.Pharm

Experience

Tenure : 8 Years

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).