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Quality Assurance Specialist (Supply Chain Management)

This job post is currently not available.

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, review and approve standard operating procedures and other related documents for compliance with established and new requirements.
  • Ability to define problems, collect data, establish facts, and draw conclusions.
  • Ability to focus regardless of circumstances and stress induced pressure.
  • Ability to drive quality culture and promote compliance behaviors.
  • Ability to take proactive approach.
  • Ability to adapt for improvement and keep up to date on most current regulatory, local and international requirements and guidelines.
  • Meticulous and systematic.
  • Have strong focus on safety, quality and timeliness.
  • Have strong critical thinking skills.

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 by ensuring that raw materials delivered and released for manufacturing meet production timelines and comply with relevant quality and regulatory requirements. You will also be expected to manage and oversee supply chain management processes such as supplier qualification, supplier performance review and complaints, and supplier management. You will also assist the Quality Department to have an oversight on the site’s GMP compliance and actively initiate and take part in continuous improvement programs.

Primary work location: Ayer Rajah Crescent, Singapor

Job Responsibilities

  • Maintains appropriate Quality oversight of supply chain and material management activities – logistics, warehouse operations, material movement and release, supplier management.
  • Maintains current Quality tracking systems and the quality metrics to proactively identify trends and atypical observations.
  • Process owner for management of raw material release process and new material introduction.
  • Deviations/Supplier Complaints - Participates in investigations, reviews and approves investigation reports; Trends and reports quality systems related information (deviations, investigations, change controls, CAPAs, related tasks etc.).
  • Change Control - Reviews and approves change control requests, leads material and/ or supplier
  • qualification activities and risk management activities from Quality perspective. Acts as Quality representative in change control meetings.
  • Audits – Performs supplier audits and internal audits. Contributes to the improvement of the quality management system, as necessary.
  • Undertakes tasks assigned by leaders as and when appropriate.

Requirements

  • Minimum bachelor’s degree in Chemical Engineering, Pharmaceutical Science or relevant
  • discipline. Diploma with 3 years or more work experiences in a GMP environment is also
  • welcomed to apply.
  • Minimum 3 years of Quality Assurance work experience in a GMP environment, preferably in the pharmaceutical/ biopharmaceutical industries. Minimum 5 years of work experience in production department of a GMP pharmaceutical/ biopharmaceutical environment is also welcomed to apply.
  • Familiar and keeping up to date with current GMP and applicable GxP regulations and standards; experience with regulatory requirements such as Singapore/HSA US/FDA, EU/EMEA etc.
  • Should ideally come with supplier quality experience (material qualification, deviation and change control management, supplier management).
  • Proficient in MS Office Suite (Microsoft Word, PowerPoint, Excel).
  • Experience with ERP, MES (Electronic Batch Records) would be an advantage.
  • 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].