Title:  Manager - 2 CQ IT

Title:

Manager 2 –  CQIT

Business Unit:

Global Quality and Compliance 

Job Grade:

G11A

Location:

Mumbai

Key Responsibilities

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.”

Position Summary –

•             Develop and maintain the quality of Computer system to ensure compliance with internal/external regulatory requirements.

•             Lead the creation and implementation of relevant standards procedures for computerize systems (SOPs)

•             Approve the periodic user access right review for global application/software

•             Ensure quality processes and standards are aligned through project rollout and completion.

•             Manage and support as QA-lead to Validation of IT projects; new system implementation or existing application including plans, protocols/scripts and reports.

•             Provide input into business decisions in the assessment and specification of to comply regulatory requirements

•             Provide support in the education and training of personnel in relevant areas of compliance and validation for IT systems.

•             Ensure key documentation of computerize systems consistently meets the required quality standards throughout its lifecycle

•             Coordinate operational change management / test activities to ensure ongoing compliance with business and regulatory requirements

•             Ensure IT quality processes and standards are aligned through collaboration with the Quality Assurance functions

•             Ensure resolution of identified quality exposures in a timely manner

•             Approve lifecycle documentation for computerized systems.

•             Ensure the availability of inventory of IT systems and infrastructure, and ensure its compliance status.

•             Manage remediation programs and prioritized based on risk.

•             Support the closure of the Global IT system related actions as required

•             Mentoring and supporting sites to resolve IT project related issues

•             Mentoring the Corporate IT for any queries / strategy

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

•             Provide support for the audit of suppliers and vendors who impact development, implementation and maintenance of site/global computerized systems.

•             Support projects for simplification and productivity enhancement initiatives.

•             Support sites before and during the regulatory audits. Timely communicate/discuss the gaps identified during the site GxP computerized system assessment to site responsible staff. Coordinate with relevant site staff for the compliance/closure of the identified gaps.

•             Perform the site GxP computerized systems assessment for ensuring 21 CFR part 11, EU Annex 11 readiness, adequate security and controls.

•             Timely communicate/discuss the identified gaps during the site GxP computerized system assessment to site responsible staff. Coordinate with relevant site staff for the compliance/closure of the identified gaps.

•             Ensure the site GxP computerized systems compliance in timely manner with the support of site compliance team for continuous improvements.

•             Support sites to ensure audit readiness with respect to computerized system validation and management.

•             Support for implementing the global Quality-IT initiatives at site level.

•             Give technical support to the site computerized system validation and management team as when requested.

Job Requirements

Educational Qualification

BSc / MSc / BPharm / MPharm

Experience

8-10 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).