
C&Q Planner
1 week ago
Key Responsibilities:
- Develop and maintain detailed C&Q schedules using project planning tools (e.g., MS Project), aligned with overall project timelines.
- Collaborate with engineering, validation, QA, QC, and operations teams to plan and sequence commissioning and qualification activities.
- Monitor progress, identify schedule risks, and implement mitigation strategies to ensure timely delivery of C&Q milestones.
- Support the development and execution of C&Q strategies, including URS, DQ, IQ, OQ, and PQ documentation and activities.
- Ensure C&Q activities comply with GMP, FDA, EMA, and other applicable regulatory standards.
- Facilitate planning meetings, progress reviews, and reporting to project stakeholders.
- Coordinate resource planning and availability for C&Q tasks, including vendor and contractor support.
- Maintain accurate documentation and change control records related to C&Q scope.
- Support audits and inspections by providing schedule-related documentation and insights.
Qualifications:
- Bachelor's degree in Engineering, Life Sciences, or related field.
- Minimum 3 years of experience in project planning within a GMP-regulated pharmaceutical environment.
- Strong understanding of C&Q processes and lifecycle documentation (URS, DQ,IQ, OQ, PQ).
- Proficiency in project scheduling software (Primavera P6, MS Project, etc.).
- Familiarity with ISPE Baseline Guides and industry best practices for C&Q.
- Excellent communication, organizational, and stakeholder management skills.
Preferred Skills:
- PMP or equivalent project management certification.
- Experience with large-scale pharmaceutical capital projects (e.g., new facility builds, equipment upgrades).
- Knowledge of computerized systems validation (CSV) and data integrity principles.
- Experience with digital validation platforms (e.g. KNEAT) or eQMS systems.
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