Validation Lead API(Ahmednagar)

Sun Pharmaceutical Industries, Inc.; Hinoba-an; On-site; PHP 1,200,000 - 1,800,000; Full time

Job summary

Sun Pharmaceutical Industries Ltd in the Philippines seeks an experienced IT professional to manage the GxP Application Inventory and serve as the Technical Owner for CSV documentation across the system lifecycle.

You will oversee CSV/QMS activities from implementation to retirement, and support internal/external audits by explaining processes and documentation related to CSV and remediation.

Qualifications

• Educational background in IT/IT pharma related fields.
• Strong understanding of CSV/QMS regulatory requirements.
• Experience executing validation activities within pharma manufacturing.

Responsibilities

• Manage inventory of GxP applications for Manufacturing & Quality IT.
• Plan and review validation deliverables for CSV projects.
• Prepare, review and approve CSV documents as Technical Owner.
• Ensure compliance of GSOPs/SOPs for CSV documentation and regulations.
• Understand Trackwise, Validator and EDMS usage.
• Support audits with processes and documentation explanations.
• Coordinate during IQ/OQ/PQ with vendors.
• Identify continuous improvement opportunities for CSV projects.
• Control CSV document management and IT-related records.
• Ensure timely completion of validation activities without extensions.
• Maintain audit readiness with compliant documentation.
• Close out deviations, CAPA, change controls timely.

Skills

Computer System Validation

IT regulatory requirements

Validation & Qualification activities

Education

BE/B. Tech

MCA

BCA

MSc IT

BSc. IT

Graduation + PGDCA

Tools

Trackwise

Validator

EDMS

Job description

Company: Sun Pharmaceutical Industries Ltd

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

The job holder will be responsible for managing the Plant GxP Application Inventory and serving as the Technical Owner for Computer System Validation (CSV) documentation related to GxP applications. They will oversee periodic CSV and QMS activities throughout the system lifecycle, from implementation to retirement. Additionally, they will support the business during internal and external audits by explaining processes and documentation related to CSV and remediation.

Responsibilities:

• To manage Inventory of GxP Applications for Manufacturing & Quality IT .
• Planning and review of validation deliverables for CSV Projects.
• Preparation, reviews and Approval of CSV documents as Technical Owner.
• Ensuring the compliance of GSOP’s /SOP’s related to Computer System Validation documentation and regulatory requirements during execution of CSV Project.
• Understanding the working and usage of Systems such as Trackwise, Validator and EDMS.
• Compliances to IT policies and procedures & regulatory requirements and support for the internal and external audits and remediation.
• Vendor coordination and support during Installation qualification (IQ), Operational qualification & Performance qualification (PQ).
• Identify the continuous improvement opportunities for CSV projects.
• Documentation and control for management of CSV documents w.r.t. IT.
• Timely completion of validation activities with zero timeline extensions
• Full audit readiness with complete and compliant documentation
• Effective and timely closure of all related QMS records (deviations, CAPA, change controls, etc.)

Based on the need job holder can travel to other sites.

Job Scope

Internal Interactions (within the organization)

System Owners from site Quality & Manufacturing and CQIT, Corporate IT.

External Interactions (outside the organization)

Business Users, External Vendors

Geographical Scope

Provide onsite support to the site & other site whenever needed Remotely.

Financial Accountability (cost/revenue with exclusive authority)

NA

Job Requirements

Educational Qualification

BE/B. Tech, MCA, BCA, MSc IT, BSc. IT, Graduation + PGDCA.

Specific Certification

NA

Skills

Computer System Validation, Understanding of IT regulatory requirements, Execution of Validation & Qualification activities.

Experience

8-10 Years in IT activities preferably in Pharma Manufacturing.

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).