Project Controller CQV
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Job Location:
Monthly Salary:
Posted on:
10 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Roles and Responsibilities
- Develop maintain and track CQV project schedules covering Commissioning IQ OQ PQ CSV and validation documentation
- Align CQV milestones with pharmaceutical manufacturing readiness and regulatory timelines
- Monitor progress against approved baselines and highlight schedule risks or delays
Cost & Resource Control
- Track CQV project budgets forecasts and actuals in regulated pharma projects
- Monitor man-hours contractor/vendor costs and change impacts related to CQV scope
- Support cost variance analysis and recovery planning
Progress Tracking & Reporting
- Collect progress data from CQV Engineering Automation and Validation teams
- Prepare weekly and monthly CQV dashboards KPIs and management reports
- Track validation documentation status execution progress deviations and punch lists
Change Control & Risk Management
- Support change control processes impacting CQV scope cost or schedule
- Track and report CQV-related risks issues and mitigation actions
- Maintain controlled records suitable for GMP audits and inspections
GMP Compliance & Documentation
- Ensure project controls follow GMP GxP and ALCOA principles
- Support inspection readiness by maintaining accurate traceable CQV records
- Collaborate with Quality Assurance and Validation during internal and regulatory audits
Stakeholder Coordination
- Act as an interface between Project Management CQV QA Engineering Automation and Vendors
- Support CQV meetings MOMs and action tracking
- Ensure alignment between technical execution and regulatory expectations
Qualifications & Experience
- Bachelors degree in Engineering Life Sciences or Project Management
- More than 7 years experience in project controls within pharmaceutical or biopharmaceutical projects
- Proven experience supporting CQV / Validation scopes in GMP environments
- Strong understanding of:
- Commissioning IQ/OQ/PQ
- CSV (21 CFR Part 11 EU Annex 11)
- GMP / GxP regulatory requirements
- Hands-on experience with project planning and reporting tools (MS Project Primavera Excel Power BI)
Key Skills & Competencies
- Pharmaceutical CQV project control
- GMP-compliant planning & reporting
- Cost tracking & forecasting
- Schedule risk identification
- Strong Excel & data analysis skills
- Audit-ready documentation control
- Cross-functional coordination
- High attention to detail
Preferred / Advantageous Experience
- Experience on pharma manufacturing facilities utilities labs or automation projects
- Exposure to FDA EMA MHRA inspections
- Experience working with EPCs or CQV service providers
- Knowledge of automation equipment utilities or cleanroom validation
Key Skills
- Project Portfolio Management
- Primavera
- Forecasting
- PMBOK
- Primavera P6
- SAP
- Accounting
- Cost Control
- SAP BW 4HANA
- Project Planning
- Microsoft Project
- Contracts
