Quality Assurance Specialist

Esco Aster; Singapore; On-site; SGD 60,000 - 80,000; Full time

Benefits offered by this job

Learning and Development

Competitive Compensation

Overseas Travel Opportunities

Job summary

A leading life sciences company in Singapore is seeking a Quality Assurance professional to oversee compliance and quality metrics. The role involves maintaining quality tracking systems, reviewing GMP records, and ensuring adherence to quality procedures. Ideal candidates will have a Bachelor's degree in Chemical Engineering or Pharmaceutical Science, along with a minimum of three years of experience in a GMP environment. The candidate should be familiar with current regulations and possess strong problem-solving and communication skills.

Qualifications

• Minimum 3 years of Quality Assurance work experience in a GMP/aseptic environment.
• Proficient in MS Office Suite and familiar with ERP/MES systems.
• Able to work independently and manage tasks effectively.

Responsibilities

• Ensure compliance and maintain quality oversight of SOPs.
• Review GMP records and participate in investigations.
• Support the Quality Department in audit activities.

Skills

Problem-solving

Quality culture promotion

Critical thinking

Adaptability

Attention to detail

Education

Bachelor’s Degree in Chemical Engineering or Pharmaceutical Science

Tools

MS Office Suite

ERP/MES systems

Job description

Join us for the world we are making, redefining biosolutions for current and future generations to come, transcending planetary boundaries, sustainability, and One Health.

Growth

We empower each other to produce better results by providing professional advancement and personal growth.

We are driven by the challenge of creating something new and discovering better opportunities.

We value a positive attitude. We make working a more pleasant experience for everyone.

Communication

We value communication, for it creates better intercultural relationships.

Competence

We focus on things that matter most and help each other drive success.

Commitment

We see the good. We work hard. We keep things in balance.

Growth

We empower each other to produce better results by providing professional advancement and personal growth.

We are driven by the challenge of creating something new and discovering better opportunities.

We value a positive attitude. We make working a more pleasant experience for everyone.

Communication

We value communication, for it creates better intercultural relationships.

Competence

We focus on things that matter most and help each other drive success.

We want our workforce to become a happier, healthier, more productive place to work.

BENEFITS

• Learning and Development
• Competitive Compensation
• Overseas Travel Opportunities for many positions

One Team, One Mission

Are you a seasoned professional looking for your next challenge? Be one of us!

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 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.

One World Biosolutions for One Health.

Who we’re looking for

• 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.

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 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

Job Responsibilities

• Maintains appropriate quality oversight of SOPs for manufacturing and operational activities.
• Maintains current quality tracking systems and the quality metrics to proactively identify trends and 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.

Requirements

• 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.