Document Controller (GMP/ BioTech/ Pharma)
Duration: 6 Months Contract
Location: Tuas
Salary : Up to $4500 depending on experience
Our client is a fully integrated, global immunotherapy powerhouse who have been working on automated and digitized processes and build continuously capabilities for specialized manufacturing, either for individualized vaccines or for large-scale products like COVID-19 vaccine.
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 Veeva, 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
Lim Pey Chyi (Apple) - [email protected]
Recruitment Consultant (R2090579)
Manpower Staffing Services (S) Pte Ltd
EA Licence: 02C3423
