Quality Assurance Director

Executive/

Executive Corporate Quality IT- CSV

CQ IT Compliance

General Manager

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. The MES CSV Executive is responsible for ensuring that the Manufacturing Execution System (MES) complies with regulatory requirements through Computer System Validation (CSV).

This role supports MES implementation, validation, and maintenance in alignment with internal QMS and regulatory requirements.

To lead and support CSV activities for MES systems including planning, execution, and documentation.

new system implementation or upgrade of existing applications in Manufacturing / Production System, Enterprise Systems to comply with regulatory guidelines.

Support for implementing the global Quality-IT initiatives at sites

To ensure compliance of all GxP computerized systems as per internal QMS and regulatory requirements.

Ensure key documentation of computerized systems consistently meets required quality standards throughout its lifecycle

Providing expertise during software development lifecycle to assure that validation of GxP IT computerize systems is planned and executed for user requirements and intended use.

Author validation plan for projects; along with the review of validation/qualification deliverables of the assigned GxP IT systems in line with organization procedures and regulatory expectations.

Perform vendors audits of new Vendor as well as of existing Vendors as required to ensure vendor's Quality Systems are effective and meet regulatory standards.

Supporting IT Infrastructure qualification to comply with regulatory guideline

Ensure quality processes and standards are aligned through project rollout

Support projects for simplification and productivity enhancement initiatives.

Perform GxP computerized systems assessment referring requirement of 21 CFR part 11, EU Annex 11, applicable regulatory standards, and internal procedures

Support sites before and during the regulatory audits.

Mentor and provide support in the education and training of personnel in relevant areas of compliance and validation for GxP IT systems.

Support the sites Computerized System for evaluating QMS wherever required and providing guidance and support in closure of the same.

Knowledge of Computer Software Assurance (CSA) requirements.

Travel Estimate

Frequent travel required, Approx. With all sites (IT, QA and IT QA)

Financial Accountability (cost/revenue with exclusive authority)

B.E

Hands-on experience with validation of MES platforms like Werum PAS-X, Rockwell or similar.

Knowledge of FDA 21 CFR Part 11 , EU Annex 11 , and data integrity principle

Experience

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).