Senior Quality Archivist & Document Control Lead

Biopharma Careers; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Biopharma Careers in Singapore is seeking a Senior Quality Assistant to promote and integrate quality into BioReliance biologics safety testing. You will perform document control and archival to ensure full compliance with GxP and SOPs.

The role requires independent work, SLU duties for the electronic document management system, and leadership in training and archiving activities to support audits and regulatory inspections.

Qualifications

• Graduate degree in life sciences or higher related degree.
• Minimum of 3–4 years of experience in a similar QA role (document control).
• Fluent in both written and spoken English.
• Awareness of biologics regulatory environment and GMP topics.
• A proactive approach to all aspects of Quality.
• Strong communication with operational teams, site QA and lab staff.
• Strong analytical and problem solving abilities.
• Organized and logical in workload planning and project delivery.

Responsibilities

• Site Lead User for the electronic document management system; links site with global ManGo team; validates upgrades.
• Archivist for GLP studies per OECD requirements.
• Manage document control processes including templates and document index databases.
• Lead training for new hires on the electronic document management system.
• Ensure document archival complies with GxP and SOPs; archive on-site and coordinate off-site.
• Support timely retrieval of documents during client audits and regulatory inspections.
• Lead or participate in projects as Document Control Subject Matter Expert.
• Represent CTS SNG site as Document Control SME in global meetings.
• Comply with Health and Safety regulations; complete required training and act on unsafe situations.
• Perform duties per GLP, GMP, and GCP.

Skills

Quality Assurance

Document control

Analytical thinking

Communication

Organization

Education

Bachelor's degree in life sciences or related field

Job description

Biopharma Careers in Singapore is seeking a Senior Quality Assistant to promote and integrate quality into BioReliance biologics safety testing. You will perform document control and archival to ensure full compliance with GxP and SOPs.

The role requires independent work, SLU duties for the electronic document management system, and leadership in training and archiving activities to support audits and regulatory inspections.