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Program manager, qualification

Cork
CareerWise Recruitment
Manager
Posted: 5 July
Offer description

Job Description

PROGRAM MANAGER, QUALIFICATION & VALIDATION required by CareerWise Recruitment for our multinational Pharmaceutical client at their facility in Galway.

The PROGRAM MANAGER, QUALIFICATION & VALIDATION is responsible for providing a project management approach and implantation for managing the qualification and validation activities necessary to bring newly built pharmaceutical manufacturing facilities into commercial operation.

Responsibilities

1. Program Management: For facilities, equipment, utilities, computerized systems, alternate source qualifications, with clear and accessible program overview and key metric visibility.
2. Qualification & Validation Management: Provide project management approach that facilitates the execution of facility, equipment, and utility qualification (IQ/OQ/PQ) in accordance with GMP and regulatory expectations.
3. Regulatory & Compliance Oversight: Ensure facility readiness for regulatory inspections and approvals, including FDA, EMA, and other health authority requirements.
4. Cross-functional Coordination: Align efforts across Engineering, Validation, Manufacturing, Quality, and Supply Chain to ensure a seamless transition into commercial operations.
5. Risk & Issue Management: Identify potential qualification and validation risks and proactively develop mitigation strategies with relevant stakeholders to keep the project on track.
6. Stakeholder Engagement: Act as the primary point of contact for internal stakeholders.
7. Budget & Resource Management: Monitor project budgets, optimize resource allocation, and ensure cost-effective execution of programs.
8. Operational Readiness & Handover: Develop and execute plans for training, process validation, and initial production batches to ensure the facility is prepared for GMP operations.
9. Continuous Improvement: Identify and implement best practices in facility qualification and validation to enhance efficiency and compliance.

Requirements:

10. Bachelor's or Master's in Engineering (Mechanical, Chemical, Biomedical, Industrial, or related field).
11. PMP, Six Sigma Black Belt, Lean Manufacturing certified preferred.
12. Regulatory Knowledge: Strong understanding of Annex I, US, and EMA GMP regulations, with practical experience in regulatory audits.
13. Minimum 5 - 8 years of experience in pharmaceutical facility qualification, validation, or technical operations.
14. Demonstrated ability to plan, design and manage significant NPI and Tech Transfer projects.
15. Strong problem solving and critical thinking skills.
16. Excellent communication, writing, presentation and data organisation skills.
17. Demonstrated interpersonal and leadership qualities.

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