Senior/Quality Specialist

ESCO ASTER PTE. LTD.; Singapore; On-site; SGD 70,000 - 110,000; Full time

Job summary

Esco Aster Pte Ltd, part of Esco Lifesciences Group, is seeking a QA professional to support GMP readiness and ongoing compliance for cell and gene therapy manufacturing in a cGMP environment. You will oversee deviations, CAPA, change controls, and document reviews on the manufacturing floor in Singapore.

The role requires 3-5 years GMP QA experience, knowledge of ICH Q7/Q9, GDP, regulatory standards, and proficiency with eQMS and electronic documentation.

Qualifications

• Bachelor's or Master’s in Life Sciences, Biotechnology, Pharmacy or equivalent.
• 3–5 years of GMP QA/Quality experience, preferably in Cell & Gene Therapy or ATMP manufacturing.
• Experience in cell and gene therapy manufacturing is an added advantage.
• Strong knowledge of cGMP, GDP, FDA/EMA standards, PIC/S, ICH Q7/Q9, Annex 1, and data integrity.
• Proficiency with quality systems (deviation, CAPA, change control, document control, batch release).
• Familiar with eQMS and electronic document systems.
• Excellent communication, analytical, problem-solving, and collaborative skills.
• Able to work independently and mentor others; strong on QA shop-floor oversight.
• Proficient in MS Office Suite (Word, Excel).

Responsibilities

• Initiate, investigate, and close deviations, and manage CAPA processes including effectiveness checks.
• Review, assess, and manage change controls related to materials, equipment, processes, and documentation.
• Perform thorough review of batch manufacturing records, logbooks, and associated documentation.
• Provide real-time QA support on the manufacturing floor during production and aseptic operations.
• Review, revise, and approve GMP documentation including SOPs, MBRs, and work instructions.
• Conduct gap assessments of processes and procedures against GMP/regulatory expectations.
• Support internal and external audits including preparation, hosting, and response drafting.
• Participate in continuous improvement initiatives and cross-functional project teams.
• Collaborate with manufacturing, QC, validation, and engineering to ensure timely quality deliverables.
• Support inspection readiness activities and promote a culture of quality.
• Train and mentor operations staff on quality procedures as needed.
• Utilize eQMS to manage workflows and records.
• Assist Quality Control with data trending and investigations.

Skills

GMP QA experience

Quality systems

Change control

Documentation review

Cross-functional collaboration

MS Office

Education

Bachelor's in Life Sciences

Master's in Life Sciences

Tools

eQMS

Job description

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. Esco Aster. One World Biosolutions for One Health.

Who we're looking for

Physical / Mental Requirements / Work Environment:

Strong leadership and communication skills.

Ability to stay focused under pressure and adapt proactively.

Critical thinker with a systematic and meticulous approach.

Curious and self-motivated to stay updated on cell/gene therapy and emerging technologies.

Committed to safety, quality, compliance, and timely delivery.

Cleanroom and GMP manufacturing settings.

Requires wearing full gowning/PPE.

May engage in overtime during campaign activities or urgent troubleshooting.

The Scope

To support Quality functions from GMP readiness to ongoing compliance for cell and gene therapy manufacturing in a cGMP environment, ensuring adherence to global regulatory standards through oversight of operations, documentation, and quality systems.

Primary work location: Ayer Rajah Crescent, Singapore

Job Responsibilities

• Initiate, investigate, and close deviations, and manage CAPA processes including effectiveness checks.
• Review, assess, and manage change controls related to materials, equipment, processes, and documentation.
• Perform thorough review of executed batch manufacturing records, critical logbooks, and associated documentation.
• Provide real-time QA support on the manufacturing floor during production, aseptic operations, and changeovers.
• Review, revise, and approve GMP documentation including Standard Operating Procedures (SOPs), Master Batch Records (MBRs), and work instructions.
• Conduct gap assessments of processes and procedures against current GMP and regulatory expectations.
• Support internal and external audits including preparation, hosting, documentation retrieval, and response drafting.
• Participate in continuous improvement initiatives and cross-functional project teams to enhance quality systems and operational efficiency.
• Collaborate with manufacturing, QC, validation, and engineering teams to ensure timely execution of quality deliverables.
• Support inspection readiness activities and promote a strong culture of compliance and quality awareness.
• Train and mentor operations staff on quality procedures and best practices as needed.
• Utilize electronic Quality Management Systems (eQMS) to manage quality workflows and records.
• Support Quality Control function as needed, including review of QC documentation, data trending, and investigations.
• Undertake other tasks as assigned by the management based on project needs.

Requirements

• Bachelor's or Master's in Life Sciences, Biotechnology, Pharmacy or equivalent.
• 3-5 years of GMP QA/Quality experience, preferably in Cell & Gene Therapy, Biologics, or ATMP manufacturing.
• Experience in working in cell and gene therapy manufacturing is an added advantage
• Strong knowledge of cGMP, GDP, FDA/EMA standards, PIC/S, ICH Q7/Q9, Annex 1, data integrity principles.
• Proficiency with quality systems (deviation, CAPA, change control, document control, batch release etc).
• Familiar with eQMS, and electronic document systems.
• Excellent communication, analytical, problem‑solving, and collaborative skills
• Able to work independently and under tight timelines; experience in Q&A shop‑floor oversight.
• Proficient in MS Office Suite (Microsoft Word,