Documentation Control Lead

The Document Control/QA Specialist
will be responsible for maintaining the lifecycle of validation documents
within an automated system. This role involves performing quality reviews of
validation protocols, ensuring compliance with internal and regulatory
standards.

Key Responsibilities:

• Manage validation documentation in automated systems, including document
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 documentation aligns
with project milestones.

• Assist in audits and inspections by providing necessary documentation.

• Ensure all document 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 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.