About the Role
We are looking for a Document Control Assistant to support the site's document management system and ensure compliance with cGMP, company policies, and regulatory requirements. You will be responsible for processing documentation changes, maintaining controlled documents, and supporting document lifecycle management within a pharmaceutical manufacturing environment.
Key Responsibilities
- Process documentation change plans and requests for the creation, revision, and control of documents through the site's validated Document Management System (DMS).
- Ensure documentation activities comply with company policies, procedures, and regulatory requirements throughout the document lifecycle.
- Support the controlled issuance of paper records, including batch records, logbooks, and Standard Operating Procedures (SOPs), to the respective departments.
- Maintain document reconciliation, archival, retention, and retrieval activities, ensuring all controlled documents are managed according to company procedures.
- Support document lifecycle management activities, including document issuance, archival, retrieval, and controlled distribution.
- Ensure compliance with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and data integrity requirements.
- Assist with document management activities to support operational excellence, site improvement initiatives, and new product introduction projects.
- Work closely with cross-functional teams to ensure documentation processes are completed accurately and on time.
- Perform other duties as assigned by the Document Control Supervisor.
Requirements
- Diploma or Degree in Life Sciences, Pharmaceutical Sciences, Chemistry, Biotechnology, Engineering, Business Administration, or a related discipline.
- Prior experience in document control, quality assurance, GMP documentation, or pharmaceutical manufacturing is preferred.
- Familiarity with Document Management Systems (DMS), cGMP, and Good Documentation Practices (GDP) is an advantage.
- Strong attention to detail with excellent organisational and documentation skills.
- Proficient in Microsoft Office applications.
- Good communication skills and the ability to work effectively in a cross-functional team environment.
Interested applicants, please email your updated CV to ************* or WA 97527630 for more information.
We regret to inform that only shortlisted candidates will be contacted.
EA Personnel: Lim Ruo Yi, Rachel (R23116144)
Company EA license No.: Recruit Express Pte Ltd (99C4599)