QMS & Doc Control Manager 20hours a week
1 day onsite
Position Summary :
This part-time role is crucial for managing our electronic quality management system (EQMS) and overseeing document management related to change control, SOPs, and regulatory filings.
The individual will ensure compliance with internal quality standards and 21CFR11 / Annex11 guidelines.
Key Responsibilities :
- Organize and manage corporate quality documents.
- Oversee document lifecycle, including creation, review, and retirement.
- Prepare quality metrics and manage GxP-related documents for regulatory submissions.
- Review documents for accuracy and compliance with SOPs.
- Develop and maintain training curricula and metrics for compliance.
- Ensure inspection readiness and coordinate documents for audits.
- Collaborate with stakeholders to enhance document processes.
Qualifications :
- BS / BA in a science field preferred; At least 3 years of experience in a GxP biopharmaceutical environment.
- Strong organizational and communication skills.
- Veeva experience highly preferred
- Proficiency in MS Office; experience with electronic document systems preferred.
- Ability to critically review and format controlled documents.
- Strong attention to detail, problem-solving skills, and the ability to multitask in a global team environment.
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