Quality Assurance Operations (QA Ops) Specialist
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.
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.
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 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 in continuous improvement programs.
Primary work location: Ayer Rajah Crescent, Singapore
- Maintains appropriate quality oversight of SOPs for manufacturing and operational activities.
- Maintains current quality tracking systems and the quality metrics to proactively identify trends and atypical observations.Product Review and Release - Ensures adherence of processes to quality procedures. Reviews GMP records to ensure compliance with cGMP requirements per written procedures (e.g. manufacturing critical logbooks, batch records, clinical data, changeover records).
- Deviations/Customer 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 request, qualification activities and risk management activities from quality perspective. Acts as Quality representative in change control meetings.
- Product Annual Review - Prepares and compiles data for updates and project status reports on site’s quality performance in Quality Review, organizes trends and recommends improvement actions.
- Audit - Participates in walk downs and internal audit program to ensure site operations and facility are maintained in inspection ready state. Assists the hosting of regulatory, certification body and customer audits. Contributes to the improvement of quality assurance systems, as necessary.
- Collaboration with other departments – Supports in IQ, OQ, and PQ protocols establishment and validation / revalidation activities. Identifies validation issues and supports development of remedial actions. Supports the review of reference standards of materials, and releases of incoming materials.
- Undertakes tasks assigned by leaders as and when appropriate.
- Minimum Bachelor degree in Chemical Engineering, Pharmaceutical Science or relevant discipline. Diploma with 3 years or more work experiences in a GMP / aseptic environment is also welcomed to apply.
- Minimum 3 years of Quality Assurance work experience in a GMP / aseptic environment, preferably in the pharmaceutical/biopharmaceutical industries. Minimum 5 years of work experience in production department of a pharmaceutical/biopharmaceutical GMP / aseptic 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
- 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].