Quality Management System 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.
Ability to author, review and approve standard operating
procedures and other related documents for compliance with established and new
requirements.
- 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.
- Adaptability and problem-solving skills to address evolving quality changes.
- Commitment to continuous learning and staying updated with industry best practices.
- 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 development, implementation, and maintenance of a Quality
Management System (QMS). You will ensure compliance with the relevant
regulations, industry standards and internal policies to optimize quality
processes and foster a quality culture throughout the organization.
Work location: Various Locations
Report to: Quality Manager
- Contribute to the design, development and implementation of the Quality Management System (QMS) or Pharmaceutical Quality System (PQS) in accordance to relevant regulations and industry standards (e.g., ISO 9001).
- Establish quality policies, procedures, and guidelines to meet regulatory requirements and improve operational efficiency.
- Conduct regular audits to access QMS compliance and identify areas for improvement.
- Liaise with external auditors and regulatory bodies to ensure adherence to industry standards and certifications.
- Drive continuous quality improvement programs and foster quality culture across the organization.
- Analyze data and metrics to identify trends, issues, and opportunities for enhancement.
- Develop and provide training programs to employees on quality standards, procedures, and best practices.
- Ensure staff awareness and competence in adhering to QMS requirements.
- Maintain comprehensive documentation of quality process, including records of audits, corrective actions, and improvements.
- Identify potential risks to quality compliance and develop risk mitigation strategies.
- Implement measures to prevent quality issues and proactive approach to risk management.
- Minimum Bachelor’s Degree in Chemical / Pharmaceutical / Biomedical Engineering, Pharmacy, Life Sciences or a related field.
- Minimum 5 years of relevant work experience in a GMP/aseptic environment, preferably in the pharmaceutical/biopharmaceutical industries or minimum 5 years of work experience in the production department of a pharmaceutical/biopharmaceutical GMP/Aseptic environment.
- Familiar and up to date with current GMP and applicable GxP regulations and standards; familiar with regulatory requirements such as Singapore’s Health Sciences Authority (HSA), US Food and Drug Administration (FDA), European Medicines Agency (EMA), etc.
- Familiar with cell culture and can implement in QMS.
- Proficient in MS Office Suite (Microsoft Word, PowerPoint, Excel).
- Strong analytical skills and the ability to interpret data to drive decisions and improvements.
- Able to work independently, a self- starter, is self-motivated and task oriented.
- Good communication skills and leadership skills to effectively collaborate with cross-functional teams.
- Proficiency in QMS software and related tools for documentation and analysis.
- Strong team player, develop positive relationships with a strong set of interpersonal skills.
- 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.
- Adaptability and problem-solving skills to address evolving quality changes.
- Commitment to continuous learning and staying updated with industry best practices.
- Have strong focus on safety, quality and timeliness.
- Have strong critical thinking skills.
Apply now by submitting a Cover Letter and CV to [email protected].