Documentation Control Lead - CQV w2role
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Job Title: Documentation Control Lead
We are seeking a Documentation Control Lead with extensive experience in managing validation documents within an automated system for a project... The ideal candidate will have strong expertise in document control, quality assurance, and regulatory compliance, specifically in the pharmaceutical industry. This role will involve maintaining the lifecycle of validation documents and ensuring they meet internal and regulatory standards.
Key Responsibilities
We are seeking a Documentation Control Lead with extensive experience in managing validation documents within an automated system for a project... The ideal candidate will have strong expertise in document control, quality assurance, and regulatory compliance, specifically in the pharmaceutical industry. This role will involve maintaining the lifecycle of validation documents and ensuring they meet internal and regulatory standards.
Key Responsibilities
- Manage validation documentation within automated systems, including document control, archiving, and retrieval processes.
- Perform quality reviews of validation protocols such as IQ/OQ/PQ protocols, test scripts, and validation reports to ensure accuracy and compliance.
- Collaborate with CQV (Commissioning, Qualification, and Validation) and engineering teams to ensure validation documentation aligns with project milestones.
- Assist in audits and inspections by providing and organizing the necessary validation documentation.
- Ensure that all document control activities comply with FDA, cGMP, and internal quality standards.
- Review and compile documentation for TOP (Turn Over Package) preparation.
- Bachelor's degree in Life Sciences, Engineering, or a related field.
- 8+ years of experience in document control and quality assurance within the pharmaceutical industry.
- Expertise in validation documentation management and quality review processes.
- Strong understanding of regulatory requirements, including FDA and cGMP.
- Excellent attention to detail and strong organizational skills.
- Experience with TOP review and compilation is a plus.
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