Project Manager - Cleaning Validation
PharmaLex
- Juncos, PR
- Permanente
- Tiempo completo
- Assess project progress through the preparation of the monthly Total Cost Management (TCM) report by project through eBuilder software; this must be reviewed with the Project Manager for approval.
- Prepare monthly projects accruals.
- Perform a Monte Carlo risk assessment using project risk register to determine project contingency.
- Perform a quarterly capital project latest estimate (LE) and the annual budget plan for capital and expense expenditures.
- Establish and manage cash flow projections.
- Audit capital project invoices prior to payment.
- Work cross-functionally within Finance, Global Strategic Sourcing and Corporate business organizations to resolve any issues with vendors.
- Participates in meetings and coordinates cost meetings with project staff.Needed qualifications:Leads and / or participates in development, qualification and validation activities for product or technology transfers Cleaning validation, Change Control and Automation experienceTrains production personnel, and other engineers/technicians.Ensures compliance with company policies, programs, and procedures, regarding to government and regulatory agencies' regulations (e.g. EEO, ADA, ISO, QSR).Schedules and coordinates major segments of complex projects to meet cost and time objectives.Conducts feasibility studies, determines manpower and cost estimates, and develops engineering criteria.Designs, develops, analyzes, troubleshoots, and provides technical skills during research and/or product development.Performs other position related duties as assigned.Knowledge and Skill Requirements: * Demonstrated understanding reviewing/writing technical documents, risk assessment reports, validation documents, IOQ protocols and final reports
- Hands-on experience supporting/executing IQ, OQ (IOQ) equipment qualification related to various cleaning processes and activities
- Thorough knowledge of cGMP/FDA regulations
- Ability to drive change and motivate others toward a common vision
- Ability to lead teams that are not direct reports
- Demonstrated facilitation, problem solving, and analytical skills
- Understanding of cGMP regulation and quality management systems for pharmaceutical operations
- Strong communication and presentation skills, both oral and written with a demonstrated ability to present key quality/department/business indicators to both first-line staff and senior management
- Strong interpersonal skills, coupled with attention to detail, excellent review skills and analytical skills