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Quality Control

2 months ago

Singapore ESCO ASTER PTE. LTD. Full time
Roles & Responsibilities

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 understand protocols, technical reports and technology transfer documents.

· Ability to understand standard operating procedures and other related documents.

· Able to commit to weekend work when needed, off in lieu will be given for work on public holidays.

· Repetitive motions due to certain laboratory techniques.

· Good Understanding of Aseptic Techniques.

· Work performed in a clean room environment wearing PPE.

· Ability to define problems, collect data, establish facts and draw conclusions.

· Ability to focus regardless of circumstances and stress induced pressure.

· Ability to take proactive approach.

· Meticulous and systematic.

· Commitment to continuous learning and staying updated with industry best practices.

· Have a strong focus on safety, quality and timeliness.

· Have strong critical thinking skills.


Job Responsibilities

· Establishment of QC procedures (drafting and reviewing QC functional SOPs including QC testing SOPs).

· Responsible for Environmental monitoring (Viable and Non-Viable) of Cleanrooms, water and gases as per SOPs.

· Responsible for the Microbiological Testing of Water/Raw Material/in-process/ finished product / stability/validation/utility samples as per approved SOPs.

· Perform GPT, Sterility Testing & Microbial Identification.

· Support Sample Management functions.

· Ensure testing support media and consumable inventory timely manner to avoid delay in testing.

· Write, review and update standard operating procedures timely manner to operate EM and Microbiology operations and to ensure that specifications are in compliance with current GMP requirements/standards.

· Maintain data integrity and appropriate traceability.

· Responsible to identify OOS/OOT/Deviation and participate in Root Cause Analysis (RCA) and recommend corrective and preventive actions as applicable.

· General lab support including housekeeping, equipment maintenance, inventory of supplies, lab supplies ordering, management of glass wares, autoclaving etc. Responsible for microbiology lab and equipment/ instrument cleanliness.

· Responsible for disposition of samples upon confirmation.

· Collaborate with other functional teams in new processes/equipment/method qualifications.

· Explore and implement new technologies for rapid release such as rapid sterility testing.

· The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor and QC Management from time to time to support GMP Facility.


Requirements

· Degree with at least 3 years or Diploma with at least 5 years of experience in QC (Microbiology and Environmental Monitoring) from a highly regulated cGMP manufacturing environment (Biologics, Pharmaceuticals & ATMPs etc).

· Candidates with experience in ATMPs (Cell & Gene) manufacturing are highly preferred but not mandatory.

· Ability to prioritize work and multitask.

· Knowledge and experience on QC laboratory operations and procedures, analytical test methods, troubleshooting and evaluation of analytical results

· Thorough knowledge and understanding of current regulatory requirements of cGMP manufacturing.

· Good knowledge and understanding of Biologics manufacturing, aseptic operations and cleanroom behavior.

· Experience cell and gene therapy operations is an added advantage.

· Demonstrated ability to supervise, train, and manage technical staff.

· Demonstrated knowledge in Quality Control operations as it relates to QC testing, method validations and QC system implementation.

· cGMP regulations and audit experience in USFDA, EU and HSA etc.

· Will be able to commit 5 working days per week in a fixed pattern.

· Excellent communication, interpersonal and organizational skills.

· Ability to speak and write in English.


Apply now by submitting a Cover Letter and CV to jobs@escoaster.com.


Tell employers what skills you have

Biochemistry
Quality Control
GMP
Investigation
Microbiology
Raw Materials
Chemistry
Biotechnology
Laboratory Techniques
Microsoft Word
Regulatory Requirements
Life Sciences
Laboratory
Manufacturing
Calibration