Validation Engineer
il y a 1 semaine
We are on the lookout for a seasoned Transfer Validation Consultant to join our team. The ideal candidate will be in charge of assessing and endorsing validation documents for transfers to Contract Manufacturing Organizations (CMOs). This pivotal position encompasses a variety of specific and technical duties.
Key Responsibilities:
- Validation Plan Writing:
- Formulate and document validation plans in adherence to regulatory standards and guidelines.
- Collaborate with internal teams to establish validation requirements.
- Review and Approval of CMO Validation Plans:
- Inspect validation plans supplied by CMOs.
- Verify the accuracy, thoroughness, and compliance of these plans with industry norms and regulations.
- Grant formal approval post-assessment.
- Difference Analysis Writing regarding CMO Validation Strategy:
- Assess validation strategies put forth by CMOs.
- Spot and document disparities in comparison to the company's protocols.
- Suggest remedies to harmonize validation strategies.
- Leveraging Document Writing:
- Create documents that make the most of existing data and research for validation.
- Enhance resource utilization and reduce duplicate efforts.
- Review of Comparison Documents and Technical Risk Assessment:
- Scrutinize and contrast technical documents to ensure uniformity and excellence.
- Conduct technical risk evaluations concerning secondary transfer procedures: formulation, filling, visual inspection, and packaging.
Skills and Qualifications:
- Degree in Life Sciences, Pharmacy, Chemistry, or a related discipline.
- Significant background in validation within the pharmaceutical or biotechnology sector.
- Thorough understanding of validation criteria and regulations (GMP, FDA, EMA, etc.).
- Prior hands-on experience in secondary transfers: formulation, filling, visual inspection, and packaging.
- Exceptional writing abilities to draft clear and concise technical documents.
- Capability to work autonomously and foster effective partnerships with internal and external teams.
- Analytical mindset with a keen eye for detail.
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