Gmp Document Controller
5 days ago
No Deviation is a provider of patient-centric solutions for the pharmaceutical industry, and we are currently seeking individuals who are passionate about joining our team. Our areas of expertise include engineering consultancy, Commissioning Qualification Validation (CQV), as well as Quality, Compliance, and Regulatory services.
We strongly uphold our core values of Empathy, Integrity, and Transparency, and we strive to create a collaborative, innovative, and inclusive work environment that fosters personal growth and development.
The GMP Document Controller is responsible for managing and maintaining technical and quality documentation within a GMP-regulated environment. This role supports engineering, quality, and project teams by ensuring all documentation complies with GDP (Good Documentation Practices) and company standards, enabling seamless project execution and regulatory compliance.
Key Responsibilities:
- Document Control:
- Oversee the lifecycle of GMP documents, including collection, distribution, version control, and archiving.
- Ensure proper formatting, naming conventions, and numbering of documents in compliance with SOPs and GDP.
- Upload and maintain project documents in electronic management systems (e.g., COMOs, EIDA).
- Project Support:
- Collaborate with project teams to manage engineering documentation and ensure timely updates throughout the project phases.
- Monitor vendor document submissions to ensure compliance with contractual and regulatory requirements.
- Coordination & Communication:
- Liaise with vendors and internal teams to track the progress of documentation for FAT (Factory Acceptance Testing) and other critical project milestones.
- Facilitate communication between cross-functional teams to ensure timely delivery of documentation.
- Audit Readiness:
- Maintain documentation in an audit-ready state to support regulatory inspections and internal audits.
- Assist in ISO9001 certification coordination and ensure documentation aligns with quality standards.
- Administrative Tasks:
- Organize and archive meeting files, including preparation of minutes and post-meeting document distribution.
- Support technical procurement documentation and ensure proper categorization and distribution.
**Requirements**:
- Bachelor's degree or diploma in a relevant field (e.g., Life Sciences, Engineering, or Business Management).
- Minimum 3 years of experience in document control or project coordination roles in a GMP-regulated environment.
- Proven experience in managing technical documentation, including FAT-related records.
- Proficiency with electronic document management systems (e.g., COMOS) and advanced Excel skills (e.g., Pivot Tables, VLOOKUP).
- Strong organizational and time-management abilities.
- Excellent communication and coordination skills.
- High attention to detail and ability to work independently or within a team.
- Familiarity with engineering documentation standards and vendor coordination.
- Experience with quality assurance or regulatory compliance documentation.
- Working knowledge of ISO9001 certification processes.
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