Documentation Control Lead
On-siteNew Brunswick, Canada
New Brunswick, CanadaOn-siteContractSenior LevelBachelors DegreeSmall
ContractSenior LevelBachelors DegreeSmall
Job Summary
Manage validation documentation in automated systems, including document control and archiving. Perform quality reviews of IQ/OQ/PQ protocols, test scripts, and validation reports to ensure compliance with FDA, cGMP, and internal standards. Collaborate with CQV and engineering teams to align documentation with project milestones and assist in audits by providing necessary records. Requires a Bachelor's degree in Life Sciences or Engineering with 8+ years of pharmaceutical document control experience.
Required Qualifications
- Bachelor's degree in Life Sciences, Engineering, or related field
- 8+ years of experience in document control and quality assurance in pharmaceutical settings
- Expertise in validation documentation management and quality review processes
- Strong understanding of regulatory requirements, including FDA and cGMP
- Excellent attention to detail and organizational skills
- TOP review and compilation
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