Sterility Assurance

**Location**
- Singapore, Central Singapore**Job Type**
- Full Time**Salary**
- $3,000 - $6,000 Per Month**Date Posted**
- 1 hour agoAdditional Details

**Job ID**
- 102611**Job Views**
- 1Roles & Responsibilities

**The Opportunity**

Esco Lifesciences Group provides enabling technologies, products and services to the life sciences and healthcare industries, supporting academic research and scientific discoveries, clinical practice, as well as biopharmaceutical R&D and manufacturing. Headquartered in Singapore, Esco has an extensive sales network in over 100 countries, direct sales and service offices in over 24 countries, 8 manufacturing and R&D hubs in the US, Europe, the UK, China, Singapore, Indonesia, and over 1500 employees worldwide.

Esco is poised to benefit from the sustained growth of the healthcare and biopharma industries in Asia and globally. Esco has achieved market leadership in China, and globally, in multiple categories within some of the fastest-growing segments — with China being its largest and fastest growing market. As a Singapore-headquartered company, Esco is a nexus of East and West, bridging technologies, products and talent across the world, with global operations spanning the US, Europe and Asia.

**Who we’re looking for**

**Physical/Mental Requirements/Work Environment**
- Ability to author or review standard operating procedures and other related documents.
- Ability to define problems, collect data, establish facts, and draw conclusions.
- Ability to take initiative, work independently and prioritize multiple projects with strong follow-through.
- Ability to analyze with a pragmatic hands-on attitude.
- Ability to prioritize and organise work accordingly.
- Ability to focus regardless of circumstances and stress induced pressure.
- Ability to communicate quality operations and compliance perspective effectively to all stakeholders and senior management

**The Scope**

You will be part of Esco Aster’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 of 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

Reporting to: QA Ops Manager

**Responsibilities include (but are not limited to)**:

- Provide microbiological and sterility expertise for GMP documents including, but not limited to, SOPs and batch records and maintenance of these documents.
- Provide support and expertise to ensure Sterility Assurance processes and Contamination Control practices are applied in relevant operations.
- Establish and maintain Contamination Control Strategy (CCS) including sterility assurance control program
- Develop, implement and maintain sterility assurance standards and processes consistent with regulatory requirements and industry standards
- Ensure all relevant continuous improvements with respect to sterile manufacturing are included in reviews and update, if applicable, of the CCS
- Establish and maintain quality in the operations / processes for cleanliness and aseptic behavior.
- Participate in continuous improvement initiatives related to personnel, process, equipment, facility, utilities, gowning and equipment flows as it pertains to CCS.
- Manage, lead and implement sterility and contamination control requirements and standards applied to the facility.
- Participate in planned shutdowns and preventive maintenance activities to support contamination control.
- Assist and participate in quality risk management activities in support of the site activities
- Be point of contact between customer / stakeholders for all implementation of sterility and contamination control issues.
- Track the health of manufacturing facility to meet GMP cleanliness requirements
- Support the improvement implementation including overseeing and managing optimization of cleaning process
- Provides expert coaching and mentoring support on sterility assurance knowledge, practices and sterility awareness as part of the developing culture for site.
- Perform other duties as assigned

**Requirements**:

- A Degree in Life Sciences, Engineering or a related discipline.
- Experience in microbiological and sterility testing, environmental monitoring, clean room qualification and management, quality control endotoxin testing and microbiological control required.
- Direct experience in sterility assurance of aseptic processing would be an advantage.
- Experience in cell culture, or cell or gene therapy would be an advantage.
- Minimum 3 years of Quality Assurance or Quality Control Sterile Processing and Microbial work experience in a GMP environment, preferably in the pharmaceutical/biopharmaceutical industries.
- Familiar and keeping up to date with current GMP