job description
Join WuXi AppTec Singapore Pte Ltd as a Document QA Scientist and play a pivotal role in ensuring the highest standards of document control and compliance in our state-of-the-art manufacturing facility. Based in the vibrant and culturally rich location of Canggu, Bali, this position offers a unique blend of professional growth and an exceptional work-life balance.
As a Document QA Scientist, you will be responsible for managing and maintaining GMP (Good Manufacturing Practice) documents, training records, and document control systems. Your expertise will ensure that all documentation adheres to regulatory standards, supporting our commitment to quality and excellence in the manufacturing sector.
This role is ideal for detail-oriented professionals with a background in quality assurance, document control, or regulatory compliance. If you are passionate about maintaining high standards and thrive in a dynamic environment, we invite you to apply and become a part of our global team.
Responsibility
- Manage and maintain GMP documents, ensuring compliance with regulatory standards and company policies.
- Oversee the document control system, including the creation, revision, and archiving of documents.
- Develop and implement training programs for staff on document control procedures and GMP guidelines.
- Conduct regular audits and inspections to ensure documentation accuracy and completeness.
- Collaborate with cross-functional teams to streamline document management processes and improve efficiency.
- Prepare and submit regulatory reports and documentation as required by local and international authorities.
- Provide guidance and support to team members on best practices in document control and quality assurance.
- Stay updated on industry trends and regulatory changes to ensure continuous compliance and improvement.
Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or a related field.
- Minimum of 3 years of experience in document control, quality assurance, or a related role within a GMP environment.
- Strong knowledge of GMP, GDP (Good Documentation Practices), and regulatory compliance.
- Excellent organizational skills with a keen eye for detail and accuracy.
- Proficient in using document management systems and Microsoft Office Suite.
- Effective communication skills, both written and verbal, with the ability to train and guide team members.
- Ability to work independently and collaboratively in a fast-paced environment.
- Certification in Quality Assurance or Document Control is a plus.