Validation Engineer
il y a 4 semaines
We are seeking an experienced Transfer Validation Consultant. The successful candidate will be responsible for reviewing and approving validation documents as part of the transfers to Contract Manufacturing Organizations (CMOs). This crucial role will involve several specific and technical tasks.
Key Responsibilities:
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Validation Plan Writing:
- Develop and document validation plans in compliance with regulatory standards and requirements.
- Collaborate with internal teams to define validation requirements.
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Review and Approval of CMO Validation Plans:
- Examine validation plans provided by CMOs.
- Ensure the accuracy, completeness, and compliance of these plans with industry standards and regulations.
- Provide formal approval after review.
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Difference Analysis Writing regarding CMO Validation Strategy:
- Analyze validation strategies proposed by CMOs.
- Identify and document discrepancies compared to the company's practices.
- Recommend solutions to align validation strategies.
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Leveraging Document Writing:
- Write documents that leverage existing data and studies for validation.
- Optimize resource use and minimize duplication of efforts.
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Review of Comparison Documents and Technical Risk Assessment:
- Review and compare technical documents to ensure consistency and quality.
- Perform technical risk assessments related to secondary transfer processes: formulation, filling, visual inspection, and packaging.
Skills and Qualifications:
- Degree in Life Sciences, Pharmacy, Chemistry, or a related field.
- Significant experience in validation within the pharmaceutical or biotechnology industry.
- In-depth knowledge of validation standards and regulations (GMP, FDA, EMA, etc.).
- Practical experience in secondary transfers: formulation, filling, visual inspection, and packaging.
- Excellent writing skills with the ability to produce clear and concise technical documents.
- Ability to work independently and collaborate effectively with internal and external teams.
- Analytical mindset and attention to detail.
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