Validation Specialist API-Toansa

Sun Pharmaceutical Industries, Inc.; Hinoba-an; On-site; PHP 900,000 - 1,700,000; Full time

Job summary

Sun Pharma is hiring a Validation Specialist at the Toansa site. The role oversees the Plant GxP Application Inventory and acts as Technical Owner for CSV documentation related to GxP applications. You will conduct CSV and QMS activities across the system lifecycle and support audits with detailed process explanations.

The candidate will validate IT systems, ensure compliance with GSOPs, SOPs, and regulatory requirements, and drive remediation efforts with cross-functional teams.

Qualifications

• BE/BTech or MCA with IT-focused degree and relevant certifications.
• Experience with validated GxP systems and CSV lifecycle.
• Familiarity with GMP/Regulatory requirements and IT infrastructure.

Responsibilities

• Manage the Inventory of GxP Applications for Manufacturing & Quality IT.
• Support validation deliverables planning and reviews for CSV projects.
• Prepare, review and approve CSV documents as Technical Owner.

Skills

Computer System Validation

IT regulatory requirements

Validation & Qualification

Education

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

Tools

Trackwise

Validator

EDMS

Job description

Select how often (in days) to receive an alert: Create Alert

Location: Toansa - Information Technology

Company: Sun Pharmaceutical Industries Ltd

Job Title:

Validation Specialist

Job Grade:

G11A

Function:

Global Information Technology

Sub-function:

Manufacturing & Quality IT

Manager’s Job Title:

Head API & RND IT India

Function Head Title:

Global Chief Information Officer

Location:

Toansa

Areas Of Responsibility

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 supporting CSV projects as the Technical Owner for Computer System Validation (CSV) documentation related to GxP applications. They will conduct periodic CSV and QMS activities throughout the system lifecycle, from implementation to retirement. Additionally, they will assist the business during internal and external audits by explaining processes and documentation related to CSV and remediation.

Responsibilities:

• To manage the Inventory of GxP Applications for Manufacturing & Quality IT.
• To support the Planning and review of validation deliverables for CSV Projects.
• Support in Preparation, reviews and Approval of Computer System Validation (CSV) documents as per implemented processes 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.
• Detailed understanding for 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 IT CSV Documents.
• 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, Validation Lead, CQIT and Corporate IT & CQA.

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

7-8 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).