Job Description

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 \xe2\x80\x94 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. The Scope You will be part of Esco Aster\xe2\x80\x99s Quality Assurance team and contribute towards the overall site mission and objectives. You will support the site\xe2\x80\x99s 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\xe2\x80\x99s FSMS (Food Safety Management System)/ISO 22000 compliance and actively initiate and taking part continuous improvement programs. Primary work location: Ayer Rajah Crescent, Singapore Reporting to: Food Safety Quality Assurance (FSQA) Manager Job Responsibilities

• Execute the FSMS to support the batch release and auditing, to ensure each batch of product has been manufactured, tested and approved for release in compliance with the applicable laws and regulations in force in the country of manufacture and applicable market authorizations.
• Review manufacturing batch records, data forms, protocol, reports and maintenance of pre-requisite programs.
• Administer, review and follow-up with Deviations and Investigations and correspondence Corrective and Preventive Action (CAPAs).
• Trend and report quality systems related information (deviations, investigations, CAPAs.
• Prepare and compile statistical quality data for client updates and project status reports on site\xe2\x80\x99s quality performance.
• Assist to track quality system related to Deviations and Investigations and correspondence Corrective and Preventive Action (CAPAs).
• Interface and communicate with cross-functional teams to ensure that production batches are reviewed and released in a timely manner.
• Support the review of reference standards of materials, and release of incoming materials.
• Support internal audit and assist the hosting of regulatory and customer audits.
• Sample preparation for third party testing.
• Ensure all team members adhere to rules and regulations of clean room behaviour.
• Undertake tasks assigned by leaders as and when appropriate.

• Bachelor\xe2\x80\x99s degree in relevant discipline.
• Minimum 3-5 years of Quality Assurance work experience in a GMP/aseptic environment, preferably in the pharmaceutical/biopharmaceutical industries.
• Familiar and keeping up to date with current GMP/Singapore Food Regulations, with flexibility to change as needed due to new regulatory requirements and technologies, as relevant for clinical and commercial supply.
• Experience with regulatory requirements such as Singapore Food Regulations/HSAUSFDA.
• Proficient in MS Office Suite (Microsoft Word, PowerPoint, Excel).
• 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 relationship with a strong set of interpersonal skills.
• Ability to maintain discipline of team members without conflict.
• Experience in Cellular Agriculture/novel food would be an advantage.
• During the start-up phase of the facility, be willing to take on expanded role to set up the team and workflow/processes as needed.