Senior Quality Validation Manager for Pharmaceutical Projects
Vor 4 Tagen
We are seeking an experienced QA Representative Manager to join our client's Pharma Operations team.
- This role will involve representing Quality in cross-functional project teams, providing oversight for commissioning, equipment qualification, and Computerized System Validation (CSV).
- The primary mission is to ensure all quality aspects are managed efficiently and in compliance with global policies, SOPs, GMP standards, and regulatory requirements.
This specific assignment will start ASAP and is planned for 6 months with a high probability of prolongation till end of 2025
Project CAPEX Support: Key Responsibilities
- Serve as the Quality Validation representative for site and global project implementation.
- Provide quality and compliance expertise for validation activities, including equipment, utilities, room qualification, and Computerized System Validation (CSV).
- Collaborate with project teams to resolve quality issues and plan QA activities.
- Review and approve design documents, risk assessments, validation protocols, reports, deviations, and change controls.
Quality Assurance Activities
- Promote compliance with data integrity and computer system validation regulations.
- Support the lifecycle of the strategic Quality Operations plan.
- Develop and implement QA training programs for production lines and associated processes.
- Perform quality risk assessments and support deviations and change control evaluations.
Operational Excellence
- Demonstrate flexibility and dedication to meet project deadlines.
- Ensure effective communication between project stakeholders and within QA teams.
- Actively promote EHS policies, ensuring safety practices are implemented and followed.
Requirements
- Proven experience in Quality Validation, specifically in pharmaceutical or biopharmaceutical environments.
- Expertise in CAPEX projects, equipment, utilities, and process validation.
- Familiarity with cGxPs, regulatory guidance, and industry standards.
- Strong organizational, analytical, and problem-solving skills.
- Team player with the ability to work independently and drive cross-functional collaboration.
Why Work with Us?
- Join a globally recognized leader in biopharmaceutical innovation.
- Collaborate on impactful projects that shape the future of healthcare.
- Work in a dynamic and inclusive environment that values growth and excellence.
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