Quality Assurance SpecialistESCO Life Sciences Group

JOB DESCRIPTION
Job Responsibilities
Maintains appropriate quality oversight of SOPs for manufacturing and operational activities.
Reviews records to ensure compliance with ISO 9001 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.
JOB QUALIFICATION
Requirements
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 GxP 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 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.
OTHER JOB REQUIREMENTS
Education
Bachelor's Degree / College Degree
Field of study
Engineering (Bioengineering/Biomedical)
Specialization
Biotechnology
JOB BENEFITS
Health Card, Travel Abroad, Others
Ability to define problems, collect data