Doentation Control Lead
Doentation Control Lead
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4-5years
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
The Doent Control/QA Specialist will be responsible for maintaining the lifecycle of validation doents within an automated system. This role involves performing quality reviews of validation protocols ensuring compliance with internal and regulatory standards.
Key Responsibilities:
Manage validation doentation in automated systems including doent control and archiving.
Perform quality reviews of IQ/OQ/PQ protocols test scripts and validation reports.
Collaborate with the CQV and engineering teams to ensure doentation aligns with project milestones.
ist in audits and inspections by providing necessary doentation.
Ensure all doent control activities comply with FDA cGMP and internal quality standards.
Requirements
Qualifications:
Bachelor s degree in Life Sciences Engineering or related field.
8 years of experience in doent control and quality urance in pharmaceutical settings.
Expertise in validation doentation management and quality review processes.
Strong understanding of regulatory requirements including FDA and cGMP.
Excellent attention to detail and organizational ss.
At least 3 years experience/ knowledge with automated systems, including programming and improving complex systems Familiarity with at least one computer coding language (such as Python, Java, C#, HTML), understanding in version control systems (like GitHub or GitLab) is a plus Able to independently contribute through development and optimization of automation technologies preferred. Able to oversee implementation of automation technologies with third parties through technical ss and project management principles Must be able to work productively in an interdisciplinary team environment Experience with Hamilton, Scinomix, Tecan or similar automated laboratory platforms preferred Good oral and written communication, problem-solving, and ytical ss Ability to influence and educate other scientists and engineers to use automation technologies as part of implementation Proficiency using PC and Microsoft Office tools Excellent organizational and time management ss Strong attention to detail GMP and Good Doentation Practice Intermediate ss with WORD (authoring/editing large technical doents with styles, tables, TOCs, track changes) Basic ss with EXCEL and PowerPoint Experience with and tolerance for high levels of challenge and change Experience with project management including capturing project requirements and deliverables, timeline development, stakeholder management and communications
Employment Type
Full Time
