Sr.Manager QA IT- CSV

Job Title

Sr.Manager QA IT- CSV

Business Unit

Global Quality & Compliance

Job Grade

G9B

Location :

Pithampur, Indore (Greenfield)

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 QAIT person is responsible for ensuring that the GxP Computerized systems complies with regulatory requirements through Computer System Validation (CSV). This role supports CS implementation, validation, and maintenance in alignment with internal QMS and regulatory requirements

Key Responsibilities

• To lead and support CSV activities for GxP systems including planning, execution, and documentation.
• Ability to manage validation timelines, coordinate with stakeholders, and handle documentation workflows.
• Manage and support for Validation of GxP Applications i.e., 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 computerizedsystems assessment referring requirement of 21 CFR part 11, EU Annex 11, applicable regulatory standards, and internal procedures
• Ensure remediation of identified gaps for systems compliance in timely manner with the support of cross functional team for continuous improvements
• Responsible to comply an internal / external audit observation.
• 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.
• Perform periodic validation reviews of the GxP application system along with the relevant stakeholders.
• Knowledge of Computer Software Assurance (CSA) requirements.

Travel Estimate

Job Requirements

Educational Qualification

M.Sc / B.Pharm / B.E

Experience & Skills

Skills : Hands-on experience with validation of GxP Computerized Systems, Strong understanding of GAMP 5, validation lifecycle, and documentation (IQ / OQ / PQ)

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

Experience : 15 to 17 Yrs

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).

Skills Required

Validation of GxP Computerized Systems, FDA 21 CFR Part 11, EU Annex 11, Documentation IQ OQ PQ, GAMP 5 validation lifecycle