Quality Control (QC) Senior Manager

at  ESCO ASTER PTE LTD

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.

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.

REQUIREMENTS

• Degree or Diploma in Microbiology, Biotechnology, or related field.
• Minimum 2 years work experience in pharmaceutical/biopharmaceutical manufacturing preferred.
• Good understanding of GMP requirements in release testing.
• Knowledge and experience on QC laboratory operations and procedures, analytical test methods, troubleshooting and evaluation of analytical results.
• Proficient in MS Office Suite (Microsoft Word, PowerPoint, Excel).
• Must be able to work in team as well as independently.
• Good communication skills and able to openly communicate and escalate any relevant issues.
• Will be able to commit 5 working days per week in a fixed pattern.
  Apply now by submitting a Cover Letter and CV to jobs@escoaster.com

• Ensure proper calibration and maintenance of Quality Control (QC) equipment.
• Perform calibration and maintenance of QC laboratory equipment working with our CMMS and as per Iso 17025 standards and relevant GLP standards.
• Support/ oversee QC laboratory equipment/system qualification.
• Monitor and maintain suitable inventory level of QC laboratory supplies.
• Conduct routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods or stability samples.
• Support and actively involve in Method development, Method Validation and Method Transfer for incoming consumables, raw materials & finished products.
• Complete QC testing in a timely manner in accordance with schedules, SOPs and workflows.
• Able to operate various analytical equipment and testing methods, including able to necessary troubleshooting.
• Able to build and lead across functional department consisting of different QC functions and supervisors / deputies / subject matter experts, from biochemistry, microbiological/sterility, environmental monitoring, biological, sampling, in-process quality control.
• Work with Analytical Sciences and Technology (ASAT) to internal or external tech transfer from developed protocols from Analytical Development to Quality control including overseeing method verification, qualification, and validation activities.
• Evaluate, analyze and report on test data and results.
• Plan out which tests should be done in house when it’s time sensitive, or in process quality control versus outsourcing based on budget and when samples are time/temperature sensitive.
• Ensure proper record keeping and data management.
• Support setting up and routine maintenance of LIMs system.
• Support and oversee 3rd party test labs and ensure test labs are qualified per our QMS.
• Support/ perform validation on testing method.
• Convey data trends, results and potential implications of quality control (QC) data to reporting manager.
• Reviews, authors, and edits documents, including deviations, change control requests, SOPs, test methods, and laboratory test plans and related technical reports.
• Escalate issues and atypical events to Supervisor/Manager.
• Adhere to all site safety requirements.
• Part of working team for contamination control strategy and providing insights and root cause analysis for microbial contamination for sterility assurance.
• Actively participates in cross functional teams (may include facilitation) and shares information, as appropriate, with direct reports.
• Training the production team on quality control measures to improve product excellence.
• Participate in self-inspection and support client audits.
• Participate in risk assessment activities.
• Provide technical support and advice on QC matters to other areas within the site: Production, Procurement, Supply Chain, Warehouse, and Process Development.
• Manage the provision of chemical and microbiological analytical services to internal/external customers to ensure that all starting materials/water samples/intermediates and final products are analyzed and tested according to the stipulated quality and regulatory requirements.
• Support future setup of central QC lab for all biosolutions within Esco Aster.
• Keep up to date with the latest trends in Quality Controls Tools.
• Undertake tasks assigned by leaders as and when appropriate.