5-7 years project management experience in GxP environments.
Strong knowledge of GxP regulations, FDA, and EMEA guidelines (including 21 CFR Part 11).
Proficient in computer system validation and GAMP 5 standards.
Excellent oral and written communication skills with a keen attention to detail.
Ability to work independently while also collaborating effectively in a team environment.
Responsibilities
Coordinate GxP validation activities among various teams.
Prepare and maintain project plans focused on validation functions.
Track, report status, and align validation activities with project timelines.
Develop evaluation methods for assessing validation workstream strengths.
Manage global project teams, engaging diverse stakeholders and vendors.
Ensure transparent communication of project issues and decisions.
Analyze program risks and maintain the RAID log accordingly.
Benefits
Flexibility in work hours to accommodate project needs.
Opportunities for professional development and training.
Collaboration with a diverse set of global vendors and teams.
Dynamic and supportive work environment emphasizing team success.
Potential for career advancement within the organization.
Full Job Description
About the job SAP Validation Project Manager
Job Requirements:
Coordinate the GxP validation activities amongst the validation and functional/ technical team members
Prepare and maintain the project plan for validation function based on overall project plan
Track and report the status of the Validation activities against the project plan
Organize validation related activities and deliverables in accordance with the project timelines.
Make sure individual validation activities are aligned with the strategic direction of the program Develop an evaluation method to assess the validation workstream strengths and identify areas for improvement
Manage Global project teams with a diverse array of Vendors, talents, and responsibilities Engage stakeholders to align validation workstream priorities, coordinate interdependencies, and navigate risks
Manage changes and intervene as needed to ensure project goals are achieved
Meet with stakeholders to make communication easy and transparent regarding project issues and decisions on services
Produce accurate and timely reporting of validation workstream status throughout the implementation (multiple releases)
Analyze program risks and update RAID log accordingly
Skills:
Project management
Excellent communication (oral and written) and attention to detail
Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude.
Knowledge of GxP regulations, FDA and EMEA guidelines including 21 CFR Part 11
knowledge of computer system validation and GAMP -5 standards
Deliverables:
Stakeholders register
Risk & Issues (RAID) Log
Program Communications Management Plan
Program Weekly/Monthly Status report
Meeting Notes I Action Items post every meeting
Project Change Request / Change Order if any v111. Go-Live Sign Off/ Final Project Acceptance
Lessons Learnt document
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