Title: Senior Manager - Corporate Quality Projects

• find yourself becoming ‘Better every day’ through continuous progress.
• exhibit self-drive as you ‘Take charge’ and lead with confidence.
• demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

• 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.

• Candidate should

• Have a balance of technical knowledge & managerial skills

• 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