Job Description

Title:
Seniorr Manager-II - Corporate Quality Projects
Business Unit:
Quality
Job Grade
G9B : Senior Manager
Location :
Baroda, Gujarat
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."
Job Profile:
Project Lead is responsible for

• To have good experience & exposure of LIMS System implementations (Project developments support, validation, enhancements & implementations) across various site

• To ensure the dynamics of computerized systems w.r.t regulatory standards (21 CFR part 11, EU Annexure 11, & GAMP 5).

• To have good experience & exposure of SAP-HANA system, well aware of SAP system functionality.

• To have very good experience & expertise of Quality Control Systems & process (Functional expertise on sample management & Stability programme)

• To have very good experience & expertise of Quality Assurance process. Specially knowledge of APQR preparation & Handle control sample management.

• To have knowledge of Quality control instruments handlings like HPLC, GC & UV for Sample Managements (Testing), Test Calculations (as per pharmacopeia general chapters & Monographs) & good understanding of Test different-different scenarios (like Dissolution & CU) for fate value check (Pass/fail).

• To provide guidance/Support sites for all the major regulatory audits by Remotely & Onsite visit

• Evaluation, assessments of different business requirements received, it's impact assessments and decision for its consideration for digitization, simplification & automations.

• To identify the roadblocks and ensure the smooth execution of assigned projects.

• Responsible to ensure smooth functioning of the team operations and routine activities.

• Encouraged and developed the subordinates to explore their capabilities and take challenge to grow further.

• To identify the actionable and accomplish the project milestone.

• To prepare and review CSAP, qualifications scripts and ensure execution of qualification.

• To prepare, ensure and support for the preparation of database and design as per compliance requirements and functional needs.

• To ensure technical training / support for each site, whenever required.

• To ensure successful handover of projects to Site/Sites & support site SME's for Stabilization of projects at sites.

• To conceptualize and frame a consolidated approach for new identified technique.

• To ensure vendor support for technical discussion on finalize of projects.

• To perform the activities as per the project plan / assigned scheduler.

• To execute, support other Quality project initiated for simplification, harmonization and productivity enhancement.

• To work in collaboration with IT, API, SGO, vendor, Site Quality and different teams for identification of the right solution /tool/Vendor, to resolve the "Specific problem" and have correct solution for the organization.

Basic Expectation:

• Candidate should

- Have a balance of technical knowledge & managerial skills
- Be able to prioritize & multi -task
- Be able to work independently with limited supervision
- Manage stakeholders & get work done
- Be able to create project plans/Charters which is efficient from a time, cost & effort perspective, while understanding at the long term impact of decisions

• Analytical & Report Creation Skills - Proficiency in Excel, Word & PowerPoint.

• Basic understanding of MySQL & Oracle database

Travel Estimate
Low
Job Requirements
Educational Qualification
M.Sc / B.Pharma / M.Pharma
Experience
17-22+ years
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).