Quality Assurance Specialist
Esco Lifesciences Group is Singapore’s 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 2017.
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.
Physical/Mental Requirements/Work Environment
- Ability to author, review and approve standard operating procedures and other related documents for compliance with established and new requirements.
- Ability to define problems, collect data, establish facts and draw conclusions.
- Ability to focus regardless of circumstances and stress induced pressure.
- Ability to drive quality culture and promote compliance behavior.
- Ability to take proactive approach.
- Ability to adapt for improvement and keep up to date on most current regulatory, local and international requirements and guidelines.
- Meticulous and systematic.
- Have strong focus on safety, quality and timeliness.
- Have strong critical thinking skills.
You will be part of Esco Aster Singapore’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 quality requirements. You will be expected to assist the Quality
Department to have an oversight on the site’s GMP compliance and actively
initiate and taking part in continuous improvement programs.
Primary work location: Ayer Rajah Crescent, Singapore.
Report
to: Quality Manager
- Maintains appropriate quality oversight of SOPs
for manufacturing and operational activities.
- Maintains current quality tracking systems and
the quality metrics to proactively identify trends ad atypical
observations.
- Product Review and Release – Ensures adherence
to processes to quality procedures. Reviews GMP records to ensure
compliance with cGMP requirements per written procedures (e.g.:
manufacturing critical logbooks, batch records, clinical data, changeover
records).
- Deviations/Customer Complaints – Participates
in investigations, reviews and approves investigation reports; Trends and
reports quality systems related information (deviations, investigations,
change controls, CAPAs, related tasks, etc).
- Change Control – Reviews and approves change
control requests, qualification activities and risk management activities
from quality perspective. Acts as Quality representative in change control
meetings.
- Product Annual Review – Prepares and compiles
data for updates and project status reports on site’s quality performance
in Quality Review, organizes and recommends improvement actions.
- Audit – Participates in walk downs and internal
audit program to ensure site operations and facility are maintained in
inspection ready state. Assists the hosting of regulatory, certification
body and customer audits. Contributes to the improvement of quality
assurance systems, as necessary.
- Collaboration with other departments – Supports
in IQ, OQ and PQ protocols establishment and validation/revalidation
activities. Identifies validation issues and supports development of
remedial actions. Supports the review the reference standards of materials,
and released of incoming materials.
- Undertakes tasks assigned by leaders as and
when appropriate.
- Minimum Bachelor’s Degree in Chemical Engineering, Pharmaceutical Science or relevant discipline Diploma with 3 years or more work experiences in a GMP/aseptic environment is also welcomed to apply.
- Minimum 3 years of Quality Assurance work experience in a GMP/aseptic environment, preferable in the pharmaceutical/biopharmaceutical industries. Minimum 5 years of work experience in the production department of a pharmaceutical/biopharmaceutical GMP/Aseptic environment is also welcomed to apply.
- Familiar and keeping up to date with current GMP and applicable GxP regulations and standards; experience with regulatory requirements such as Singapore/HAS, US/FDA, EU/EMEA, etc.
- Proficient in MS Office Suite (Microsoft Word, PowerPoint, Excel).
- Experience with ERP, MES (Electronic Batch records) would be an advantage.
- 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 relationships with a strong set of interpersonal skills.
Apply now by submitting a Cover Letter and CV to [email protected].