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Quality Assurance Operations Specialist

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 20 countries, 8 manufacturing and R&D hubs in the US, Europe, the UK, China, Singapore, Indonesia, and over 1300 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.

The Scope

You will be part of Esco Aster Singapore Manufacturing’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 continuous improvement programs.

Primary work location: Ayer Rajah Crescent; occasional Changi.

Reporting to: QA Ops Manager.

Responsibilities

  • Execute the Pharmaceutical Quality Systems to support the batch release and GMP auditing, validation/qualification and revalidation/requalification program 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 clinical data transfers.
  • Administer, review and follow-up with Deviations and Investigations and correspondence Corrective and Preventive Action (CAPAs) as well as Change Controls and the correspondence Child Tasks.
  • Trend and report quality systems related information (deviations, investigations, change controls, CAPAs, child tasks etc.).
  • Prepare and compile statistical quality data for updates and project status reports on site’s quality performance in Quality Review.
  • Assist to track quality system related to Deviations and Investigations and correspondence Corrective and Preventive Action (CAPAs) as well as Change Controls and the correspondence Child Tasks.
  • Interface and communicate with cross-functional teams to ensure that production batches are reviewed and released in a timely manner.
  • Work closely with the Quality Control, Commissioning/Qualification and Validation, the Production, the Engineering, and Process Development teams to ensure products produced meet the GMP regulatory standards and quality expectations.
  • 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.
  • Undertake tasks assigned by leaders as and when appropriate.

Requirements

  • Bachelor’s degree in relevant discipline.
  • Minimum 3 years of Quality Assurance work experience in a GMP environment, preferably in the pharmaceutical/biopharmaceutical industries.
  • Familiar and keeping up to date with current GMP, 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/HSA US/FDA, EU/EMEA etc
  • Experience with ERP, MES (Electronic Batch Records) would be of an advantage.
  • 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.

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.

Apply now by submitting a Cover Letter and CV to [email protected].

For other job openings in Esco Lifesciences Group within the respective geographies, kindly refer to corporate website.