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Website Aditi Consulting
Aditi Consulting
Company : Aditi Consulting
Job Functions:
Review and approve Requirement Specifications, Design Specifications, Testing Protocols, Validation Plans, Summary Reports, and Requirement Traceability Matrices
Review and approve operational and administrative SOPs
Review and approve Change Controls (QA Contact role for CCMS and ServiceNow changes)
Review and approve Data Integrity Assessments
Review and approve System Life Cycle Documents (i.e. test protocols) before use in production.
Applies analytical skills to evaluate and interpret complex situations/problems using multiple sources of information (e.g., Qualitative information, Quantitative research, Trend data)
Anticipates and prevents potential problems
Independently develops solutions that are thorough, practical and consistent with functional objectives
Top 3 Must Have Skill Sets:
Prior knowledge in SAP validation preferred
Hands on experience with all phases of Software Development Life Cycle (SDLC)
Experience and knowledge with GxP and CSV/CSA requirements
Education/Experience:
Doctorate degree or Master’s degree and 3 years of directly related experience or Bachelor’s degree and 5 years of directly related experience.
Previous experience leading teams, projects, programs or directing the allocation of resources.
COMPETENCIES/SKILLS:
Prior knowledge in SAP validation preferred
Project management skills
Strong organizational skills, including ability to follow assignments through to completion.
Initiate and lead cross functional teams.
Collaborate and communicate with higher level outside resources.
Skill and knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation, and process development.
Strong communication (both written and oral), facilitation, and presentation skills.
Strong skill in working independently and to effectively interact with various levels.
Able to manage performance issues and conflict
Ability to evaluate documentation/ operations according to company and regulatory guidelines
Ability to interact with regulatory agencies
Demonstrate the companies Values/Leadership Practices
Compensation:
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on a number of factors, including but not limited to, a candidate’s qualifications, skills, competencies, experience, location and end client requirements).
Benefits and Ancillaries:
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions.