.. organization to tax regulating bodies during audits or reviews Ensure the support to audits by statutory, internal and tax auditors and management of annual tax assessments Handle litigations and management of annual tax assessments Lead the development and ongoing management of internal policies relating .. read more
JD- 6 to 10+ years’ experience in Computer System Validation or Quality management or Business Analysis in GxP application area
Has working experience in any one or two of the following domains - Clinical Development and Supply Chain, Drug Discovery, MES, QMS, LIMS, Data Integrity Platforms
Guide the project team with the right set of applicable project deliverables based on project type and category while catering to the SDLC
Application of FDA guidance’s and industry standards (i.E., GAMP)? . Strong understanding on 21 CFR Part 11 and Risk Based Approach with the ability to guide the project teams
Possesses strong communication skills to interact with business stake holders (Technology Leader, Project Manager, Business Owner Business users SME) and interpret business rules and requirements and documents them for software development.
Expertise in documenting guiding various SDLC Deliverables including Requirements Specification User Stories, Criticality Assessment, Test Plan, Design Documentation, Validation Plan, Risk Assessment, Validation Strategy Test Planning, Validation Test Summary, Requirement Trace Matrix.
Possesses strong communication skills to interact with business stake holders (Technology Leader, Project Manager, Business Owner Business users SME) and interpret business rules and requirements and documents them for software development.
Should be able to handle and guide multiple GxP projects
Ability to work with project team to facilitate interaction between Project team and Business Stake holders.
Ability to manage and provide guidance train the team on Policies, end to end SDLC Process, Procedure and Tools
Trains the project team on the relevant procedures associated with different SDLC processes and Tools
Strong in Project Management tools like JIRA
Manage Project priorities based upon identified risks.
