Consultant Technology Transfer - Fill & Finish
We are seeking an experienced Consultant for a 6 months contract to lead Tech Transfer and New Product Introduction (NPI) activities for one of our pharmaceutical clients. The ideal candidate will have a strong background in Fill & Finish operations, process validation, and regulatory compliance, with the ability to manage cross-functional teams and drive projects from initiation to completion.
Responsibilities:
- Drive the full life cycle of customer projects, including tech transfer and NPI activities.
- Lead a team of SME to ensure successful project delivery in terms of quality, cost, and timelines.
- Plan and execute validation activities for Fill & Finish processes.
- Draft and review validation protocols and associated reports.
- Ensure compliance with regulatory standards (FDA, EMA, etc.) and Good Manufacturing Practices (GMP).
- Collaborate with production, quality, engineering, and tech transfer teams to optimize processes.
- Control project scope and manage amendments or scope changes as needed.
- Identify and resolve issues related to process validation and tech transfer.
Key Competencies:
- Proven expertise in technology transfer for aseptic filling lines.
- Strong experience (7 years+) in New Product Introduction (NPI) within Fill & Finish.
- In-depth knowledge of GMP and international regulatory standards.
- Ability to draft clear and precise validation documentation.
- Strong project management and problem-solving skills.
- French and English mandatory - 4 days onsite per week
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