Quality System Specialist (Document Controller)
This job post is currently not available.
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 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 communicate and work with all levels in the organization.
- Ability to work with many types of files.
- Ability to organize and preserve paper and electronic documents.
- Ability to maintain confidentiality regarding sensitive information and documents.
- Meticulous, systematic and well-organized.
- 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 GxP operational activities 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 GxP 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.
- Reviews cGMP records to ensure compliance with cGMP requirements per written procedures (e.g. manufacturing critical logbooks, batch records, clinical data, changeover records).
- Maintains hard copy and electronic control documents and records.
- Manages file maintenance program for all documented information, including intellectual properties from customers and/or external providers.
- Performs documentation management and distribution; record reconciliation, keeping and filing of all controlled documentation.
- Ensures all documents are up-to-date.
- Keeps other personnel updated on new document versions and how to obtain access.
- Controlled prints and distributes documents as needed.
- Retrieves documents and records as needed.
- Ensures all documents and files are clearly labelled and indexed and that this information is consistent with the naming and numbering system.
- Ensures all information is readable with no deterioration and legibility issues.
- Handles records across various departments to prevent loss of integrity and improper use.
- Establishes record retention timelines and maintains records to the defined timelines.
- Performs periodic review of archived documents and records based on retention timelines.
- Handles records disposition after retention period.
- Identifies and resolves document control related issues.
- Deviations/Customer Complaints - Participates in investigations, reviews investigation reports; Trends and reports quality systems related information (deviations, investigations, change controls, CAPAs, related tasks etc).
- Undertakes tasks assigned by leaders as and when appropriate.
- Certificate, Diploma or Advanced Diploma in Chemical Engineering, Pharmaceutical Science or relevant discipline. GCE ‘A’ levels school leavers are welcome to apply and will be considered for an entry level position.
- Minimum 2 years of work experience in ISO 9001, ISO 13485 or cGMP document and/or records management or similar work environment would be an advantage.
- Proficient in MS Office Suite (Microsoft Word, PowerPoint, Excel).
- Experience with electronic DMS, ERP, MES (Electronic Batch Records) would be an advantage.
- 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. would be an advantage.
- Able to work independently, self-starter, self-motivated and task oriented as well as a strong team player.
- Fast learner and with a “can-do” attitude.
- Good communication skills, diplomatic and able to openly communicate and escalate any relevant issues.
- 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].