Manager Projects
Bangalore
Steering work encompassing project planning & project status tracking, resourcing, operations, risk identification and mitigation & forecasting Ensure Quality & Compliance for the entire J&J IRIS program, starting from Compliance Analysis till project closure Ensure J&J IRIS team gets the required training on J&J SDLC, mandatory and role based training courses Strict adherence to J&J SDLC, Policies, Procedures and applicable regulations with appropriate Quality Gates across Phases Agency Inspection readiness- through internal audits Reviewing & approving CSV deliverables like user requirements, system specifications, Validation Plan, Qualification Plans, SOPs, IQ/OQ/PQ, Traceability matrix, Design Specs, and validation summary reports. Offering guidance in validation activities for projects involving GxP relevant computer systems Reviewing and approving computer system validation work products, assuring thoroughness of validation planning and making appropriate progress towards timely completion of validation deliverables. Steering work pertaining to FDA regulated environment with good understanding of cGxP (cGMP, cGDP, cGAMP, cGLP) standards and Risk Based validation. Estimating / obtaining management support for the time, resources & budget required to perform the testing. Organizing the kick-off meeting; defining the strategy. Identifying training requirements; developing the test plan for the tasks, dependencies and participants Required to mitigate the risks to system quality and obtain stakeholder support for this plan. Ensuring content and structure of all testing & validation documents / artifacts is documented and maintained. Documenting, implementing, monitoring & enforcing all processes for testing & validation as per standards defined by the organization; checking/ reviewing the Test Cases documents. Keeping a track of the new requirements / change in requirements of the Project.
