Senior Document Controller
1 month ago
KPC International began operations in 2001, our team of Engineers and Scientists have helped our clients achieve project success all over the world within the pharmaceutical and biopharmaceutical space.
Specialising in Plant Facility Start-Up from Strategy and Planning to Execution, through to Operational Readiness. We are proud to support our clients in delivering their life changing products to patients.
We are currently looking for 2 experienced Doc Controllers to join us here at KPC - One to be based in Wales / UK and one can be based on site in projects across Europe.
Responsibilities
- Document Management: Organizing, categorizing, and controlling all site-related documents, ensuring easy retrieval and accessibility. Managing the creation, review, and approval of commissioning and qualification documents, ensuring alignment with project requirements. Facilitating the workflow of documents through the approval process, including managing electronic approval systems and ensuring timely reviews.
- Version Control: Implementing a robust version control and maintaining accurate versions of documents to ensure compliance with regulatory standards and facilitating updates as required.
- Quality Compliance: Ensuring documents meet quality standards, regulatory requirements, industry standards and Good Documentation Practices (GDP).
- Collaboration: Working closely with cross-functional teams to gather, update, and disseminate information accurately.
- Training Support: Assisting in the development and implementation of training programs related to document control processes.
- Audit Support: Preparing and providing documentation for internal and external audits, ensuring compliance, and addressing audit findings.
- Electronic Document Management Systems (EDMS): Proficiency in utilizing EDMS for efficient document control and management. Like SAP, Veeva (VQD), COMOS..etc.
- Communication: Facilitating effective communication regarding document-related processes and changes within the organization.
- Continuous Improvement: Identifying opportunities for process improvement within the document control system to enhance efficiency and compliance and adherence to best practices.
- Maintaining the integrity of documentation, ensuring that processes adhere to quality standards and regulatory guidelines.
Requirements:
- High School Diploma or Equivalent qualifications to meet the demands of document control in a GMP-compliant manufacturing environment, such as a pharmaceutical or biotechnology facility.
- Certifications related to document control, quality management systems, or regulatory compliance
- 5+ Years of Experience in a regulated industry such as pharmaceuticals, biotechnology, or healthcare
- Proficiency in using document management software, Microsoft Office Suite and other relevant tools
- Attention to detail and accuracy are essential for ensuring the integrity and compliance of documentation.
- Familiarity with Good Manufacturing Practices (GMP) or other relevant regulatory standards
If you have experience in CQV, Doc Control, Turnover, Clean Utilities, Process Engineering, Documentation, HVAC, E&I, or Automation please do reach out to gavin.ong@kpc-international.com
KPC-International is an Equal Opportunity Employer who offer an inclusive environment where you can broaden you experience, perspective and skills to help make an impact on the lives of others.
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