Senior Quality Assistant

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

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

Your Role

Senior Quality Assistant is to promote and integrate quality into every aspect of our BioReliance® biologics safety testing business in Singapore. The role is to perform document control and document archival to support all aspects of quality operations to ensure that laboratory testing operates in full compliance with GxP and Standard Operating Procedures (SOPs).

The post holder will be able to perform the following functions independently, with minimal guidance.

What You Do

• Site Lead User (SLU): for electronic document management system and is the connection between the site and the global ManGo team. Performs validation testing of the ManGo system as required e.g. for upgrades.
• Designated archivist for GLP studies per OECD requirements.
• Document control: Responsible for managing the document control process including management of templates and maintaining document index databases.
• Document control: Leads training for new hires with regards to the use of the electronic document management system
• Document archival: Ensure compliance with GxP regulations and SOPs with regards to document archival. Perform document archival in a timely manner.
• Document archival: Responsible for document archival on-site and coordination for off-site archival.
• Responsible for supporting timely retrieval of requested documents (on site or off site) during client audits and regulatory inspections.
• Lead and/or participate in projects as Document Control Subject Matter Expert.
• Represent CTS SNG site as Document Control Subject Matter Expert in global meetings.
• Comply with Health and Safety Executive regulations and undergo relevant training modules when required and actively takes necessary action when encountering unsafe situations.
• Perform their duties according to the principles of Good Laboratory (GLP), Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP).

Who You Are

• Graduate degree in life sciences or higher related degree
• Minimum of 3 – 4 years of experience, within a similar Quality Assurance role i.e. document control.
• Shows a desire and motivation to work in Quality and regulated environment.
• Awareness of Biologics regulatory environment and GMP manufacturing topics.
• A proactive approach to all aspects of Quality.
• Fluent in both written and spoken English.
• Good communicator, dealing directly and effectively with operational teams and site QA and lab colleagues routinely.
• Strong analytical and problem solving abilities.
• Organized and logical in defining workload and delivering projects.

What we offer:

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!