
Document Control Specialist
2 weeks ago
Role Description:
- This role involves maintaining a comprehensive list of quality agreements and alerting relevant teams as needed.
- The ideal candidate will ensure the integrity of information and data in documents, fostering trust and accuracy.
- Responsibilities include periodic review of documents, procedures, and their impact assessment to drive continuous improvement.
- Effective training on documentation-related processes and systems is essential for success in this position.
- The successful candidate will communicate problems and suggest workable solutions related to documentation, driving results-oriented decision-making.
- Key responsibilities include creating and editing documents following established guidelines, ensuring compliance with divisional SOPs, GDP, and configuration manual requirements.
- Supporting R&D employees with Quality and R&D documentation preparation, processing, and delivery is critical to this role.
- Document control, including creation, issuance, and management, will be handled by the selected candidate with minimal supervision.
- Providing effective training on documentation processes and systems is vital for team success.
- The ideal candidate will ensure that all documentation is complete, correct, and meets quality schedules, promoting a culture of excellence.
- Coordinating and supporting R&D employees in documentation-related issues will be a key responsibility.
- Process improvement and updating corresponding procedure(s) will be essential skills required for this role.
- Quality activities during internal/external audits and other quality projects will be supported by the selected candidate as needed.
- Issuance and effectiveness of documents in TcU application will be managed by the ideal candidate.
- Support will be provided on the preparation of the Site-Quality review as necessary.
- Project management, including managing change controls using client's in-house quality systems like TW8 and TcU, will be a critical aspect of this role.
Requirements:
- Strong organizational skills and prioritization abilities are essential for this role.
- Effective communication skills, negotiation, and conflict resolution are must-haves for success.
- Good analytical skills to identify errors in documentation and take corrective action are required.
- Fluency in English (both written and oral) is necessary.
- In-depth knowledge of document processing and data management is essential.
- Proficiency in Microsoft office tools (MS Word, MS Excel, MS PowerPoint, or SharePoint) is required.
- Ability to effectively train R&D employees and support their activities is crucial.
- Responsiveness to customer needs within job scope is vital.
- Ability to work under minimal supervision is necessary.
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