**Position:** Manager-1 - Corporate Quality Projects **Grade:** G10 **Education:** M.Sc / B.Pharma / M.Pharma **Job Location:** Vadodara **Job Profile:** LIMS 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. + 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, its 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 SMEs 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 We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.