Quality Management System Specialist

**The Opportunity**

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 Biosolutions for One Health.

**Key Skills and Competencies**

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.

**The Scope**

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

**Responsibilities**:

- 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.

**Requirements**:

- 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 problem