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Quality Assurance Operations Manager
3 weeks ago
**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 Singapore’s Quality Leadership team and contribute towards the overall site mission and objectives. You will contribute to the Quality team’s overall responsibility of overseeing the site’s GMP operational activities and product release to ensure compliance and meeting of quality requirements.
Primary work location: Ayer Rajah Crescent, Singapore
**Responsibilities**:
- Align the QA Function to achieve the goals of the Quality Department and the Site; communicate the needs of the QA Function to the Quality management.
- Lead and develop QA Function members to build a self-managing and high performing team.
- Manage the batch record review and release process 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.
- Interface and communicate with cross-functional teams (Process Development, Production, Tech Transfer, Business Development and Quality Control) to ensure that production batches are reviewed and released in a timely manner.
- Review and approve reference standards of materials.
- Manage the release of incoming materials.
- Manage investigations, deviation, CAPA and Change Control.
- Perform routine product quality review to identify risk factors.
- Review and approve procedures, protocols as required to ensure they are current and compliance with company policy, procedure and regulatory requirements.
- Conduct internal audits, participate in walk-through to ensure GMP readiness.
- Manage supplier qualification and management process.
- Manage the Learning and Training system.
- Support audits and inspections, by internal, collaborator and regulatory bodies.
**Authority**
- Manage a team of individual contributors - QA Ops specialists.
**Requirements**:
- Degree in Biotechnology/Chemical Engineering/Bioengineering/Life Sciences or related studies.
- Minimum of 8 years’ experience in a cGMP pharmaceutical QA role, with at least 3 to 5 years in a supervisory role or similar capacity.
- 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.
- Appropriate understanding of cGMP and regulatory requirements of the pharmaceutical industry.
- Experience with preparing quality regulatory submissions for authorities such as USFDA, EU, WHO, and Singapore MOH.
- Experience with 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 t
