Manager Corporate Quality Projects

Job Description

Position: Manager-1 - Corporate Quality ProjectsGrade: G10Education: M.Sc / B.Pharma / M.PharmaJob Location: VadodaraJob 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.

Locations: Ahmednagar - Plant

Keyskills :
lims implementation quality control systems quality assurance processes sap hana expertise technical project management instruments enhancements supervision productivity enhancement sap system