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Quality Systems Specialist

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 tofocus 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 Systems team and contribute towards the overall site mission and objectives. You will support the Quality Systems at a central level to ensure efficient and compliant GMP operations across the Company’s sites.

Job Responsibilities

  • Assist in the implementation and maintenance of Quality Systems, including but not limited to Deviation, Change control, CAPA, Document control, Training records, Complaints monitoring, Internal and External Audit, Supplier Management etc.
  • Perform supplier qualification and management process.
  • Perform and manage internal audit and assist the hosting of regulatory and customer audits.
  • Provide subject matter expertise on Quality Systems and management in cGMP.
  • Support the training of personnel on Quality Systems and their workflow and processes.
  • Work closely with the Quality Assurance, Quality Control, Commissioning/Qualification and Validation, the Production, the Engineering, and Process Development teams to ensure Pharmaceutical Quality System is set up, implemented and complies to the GMP regulatory standards and quality expectations.
  • Undertake tasks assigned by leaders as and when appropriate.

Requirements

  • Bachelor’s degree in relevant discipline.
  • Minimum 3 years work experience in a GMP environmental, preferably pharmaceutical/biopharmaceutical manufacturing facility related to pharmaceutical quality system .
  • Applicants with prior experience in QA/QC related roles with familiarity of Quality Systems may also be considered.
  • Familiar and keeping up to date with current cGMP, 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 Simploud quality system will be 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].