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. Who we\xe2\x80\x99re 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\xe2\x80\x99s Quality Leadership team and contribute towards the overall site mission and objectives. You will contribute to the Quality team\xe2\x80\x99s overall responsibility of overseeing the site\xe2\x80\x99s GMP operational activities and product release to ensure compliance and meeting of quality requirements. Primary work location: Ayer Rajah Crescent, Singapore Job Responsibilities

• Align the Quality Control (QC) team to achieve the goals of the Department and the Site; communicate the needs of the QC team to the Quality management.
• Lead and develop QC team to build a self-managing and high performing team.
• Establish and qualify required analytical test methods on raw materials, intermediates, finished products and utilities.
• Ensure testing are completed in a timely manner and in accordance with site\xe2\x80\x99s requirements and international regulations.
• Ensure QC laboratory analytical equipment are calibrated and maintained, and analytical methods are validated or verified accordingly.
• Establish and manage the environmental monitoring, incoming materials sampling, utilities sampling program for the site.
• Coordinate with cross-functional teams e.g. Manufacturing, Warehouse and Engineering on sampling and testing schedules.
• Provide technical expertise on all QC matters to ensure compliance to internal and external regulations.
• Develop and implement continuous quality improvements in the QC laboratory.
• Participate in internal and external audits and follow up on audit findings.
• Establish, write and maintain documentation e.g. SOPs, reports, quality control criteria.

Authority

• Manage a team of individual contributors \xe2\x80\x93 QC specialists; technicians.

Requirements Minimum Requirements

• Degree in Chemistry/Biology/Pharmaceutical Sciences or related studies.
• Minimum of 8 years\xe2\x80\x99 experience in a cGMP pharmaceutical QC role, with at least 3 to 5 years in a people supervisory role and 3 to 5 years in management of QC Lab.
• Familiar with cGMP operations in drug products, and in drug substances (preferred).
• Familiar with working in a cGMP environment 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.
• Knowledge of cGMP and regulatory requirements of the pharmaceutical industry.
• Experience and knowledge in QC laboratory procedures, troubleshooting, evaluation of analytical results and analytical test methods.
• Experience with LIMS, ERP, MES (Electronic Batch Records).
• 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.
• Experience in supervising and maintaining high performing team, whilst being a strong team player to work with both internal and external stakeholders.
• Develop positive relationship with a strong set of interpersonal skills and able to provide guidance and obtain buy in from all levels of organisation.

Apply now by submitting a Cover Letter and CV to jobs@escoaster.com.