Quality Assurance Specialist (Cellular Agriculture, Novel Foods)
Esco Lifesciences Group, is Singapore’s most globalized life
sciences company, with annual revenues close to SGD 200M and global operations
in over 20 countries across North America, Europe and Asia.
Esco Aster Pte Ltd is an affiliate of Esco Lifesciences Group and
was first introduced in 2017.
At Esco Aster Pte Ltd, we are a contract development and
manufacturing organization founded and deeply rooted by scientists enabling
fellow scientists to translate their bench work into commercially available
products and services at affordable prices.
The work we do creates a remarkable and lasting impact on our
world. Join us as we redefine healthcare for the current and future generations
to come.
Esco Aster.
One World. One Health.
You will be part of Esco Aster’s Quality Assurance team and contribute towards the overall site mission and objectives. You will support the site’s GMP operational activities and product release to ensure compliance and meeting of quality requirements. You will be expected to assist the Quality Department to have an oversight on the site’s FSMS (Food Safety Management System)/ISO 22000 compliance and actively initiate and taking part continuous improvement programs.
Primary work location: Ayer Rajah, Singapore
Reporting to: Food Safety Quality Assurance (FSQA) Manager
- Execute the FSMS to support the batch release and auditing, to ensure each batch of product has been manufactured, tested and approved for release in compliance with the applicable laws and regulations in force in the country of manufacture and applicable market authorizations.
- Review manufacturing batch records, data forms, protocol, reports and maintenance of pre-requisite programs.
- Administer, review and follow-up with Deviations and Investigations and correspondence Corrective and Preventive Action (CAPAs).
- Trend and report quality systems related information (deviations, investigations, CAPAs.
- Prepare and compile statistical quality data for client updates and project status reports on site’s quality performance.
- Assist to track quality system related to Deviations and Investigations and correspondence Corrective and Preventive Action (CAPAs).
- Interface and communicate with cross-functional teams to ensure that production batches are reviewed and released in a timely manner.
- Support the review of reference standards of materials, and release of incoming materials.
- Support internal audit and assist the hosting of regulatory and customer audits.
- Sample preparation for third party testing.
- Ensure all team members adhere to rules and regulations of clean room behaviour.
- Undertake tasks assigned by leaders as and when appropriate.
- Bachelor’s degree in relevant discipline.
- Minimum 3-5 years of Quality Assurance work experience in an aseptic environment, preferably in the pharmaceutical/biopharmaceutical industries.
- Familiar and keeping up to date with current Singapore Food Regulations, with flexibility to change as needed due to new regulatory requirements and technologies, as relevant for clinical and commercial supply.
- Experience with regulatory requirements such as Singapore Food Regulations/HSAUSFDA.
- Proficient in MS Office Suite (Microsoft Word, PowerPoint, Excel).
- Able to work independently, self-starter, self-motivated and task oriented.
- Good communication skills and able to openly communicate and escalate any relevant issues.
- Strong team player, develop positive relationship with a strong set of interpersonal skills.
- Ability to maintain discipline of team members without conflict.
- Experience in Cellular Agriculture/novel food would be an advantage.
- During the start-up phase of the facility, be willing to take on expanded role to set up the team and workflow/processes as needed.
Apply now by submitting a Cover Letter and CV to [email protected].