Join Our
Team

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.

Who we’re looking for

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.

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 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. 

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.

Apply now by submitting a Cover Letter and CV to [email protected].