The Opportunity
Esco Lifesciences Group is Singapores most globalized life sciences company, with annual revenues close to SGD 200M and global operations in over 42 locations and 26 direct countries across North America, Europe, Asia, Oceania.
Esco Aster Pte Ltd is an affiliate of Esco Lifesciences Group and was first incorporated in
Esco Aster is a contract research development and manufacturing organization founded and deeply rooted by scientists enabling fellow scientists to translate their bench work into commercially available products at affordable prices.
Our scientific work is in emerging and frontier biology utilizing cells as a final product or deriving products from cells which often we use cells as the factory to derive our target product.
Our first commercial breakthrough success is Esco Aster is commercially first in class being first in the world to be certified for cultivated/cell-based meat to FSSC 22000 and by a competent food regulatory body.
We are first in the region to operate an end-to-end integrated full cell line creation/immortalization or engineered cell line, cell culture process development, analytical development for stem cells and exosomes with full cGMP Capabilities from Drug Substance and small-scale fill & finish for final Cell Therapy Product.
The work we do creates a remarkable and lasting impact on our world. We offer you an opportunity to be part of this exciting journey to own your career and firsthand exposure to new emerging modalities supporting translational sciences.
Join us as we redefine BioSolutions for One World and One Health for the current and future generations to come.
Esco Aster.
One World Biosolutions for One Health.
The Scope
You will be part of Esco Asters Quality Assurance team and contribute towards the overall site mission and objectives. You will support the sites 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 sites 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
Job Responsibilities
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 sites 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.
Requirements
Bachelors 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 [Confidential Information].
