GMP Documentation Control Specialist

Racer Technology Pte Ltd; Singapore; On-site; SGD 39,000 - 58,000; Full time

Job summary

Racer Technology Pte Ltd is seeking a document control specialist to oversee SOP quality, manage controlled documents, and maintain records for manufacturing and operations. The role requires adherence to cGMP/GDP standards with on-the-job training provided.

Responsibilities include reviewing records for compliance, maintaining DMS/ERP/MES data, labeling and indexing documents, retaining records on schedule, and ensuring accessibility. East area, Changi South.

Qualifications

• Certificate, Diploma or Advanced Diploma in Chemical Engineering, Pharmaceutical Science or relevant discipline.
• Minimum 2 years of work experience in ISO 9001, ISO 13485 or cGMP document/records management 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 with GMP and GxP regulations; experience with regulatory requirements such as Singapore/HSA, US/FDA, EU/EMEA 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 communicate issues clearly.
• Comfortable to work at East area, Changi South.

Responsibilities

• Maintains appropriate quality oversight of SOPs for manufacturing and operational activities.
• Reviews cGMP/GDP records to ensure compliance with cGMP/GDP requirements per written procedures (e.g. DHR, manufacturing/batch records, changeover records).
• Maintains hard copy and electronic control documents and records.
• Manages file maintenance program for all documented information including intellectual properties from customers/external providers.
• Performs documentation management and distribution; record reconciliation, keeping and filing of all controlled documentation.
• Ensures all documents are up-to-date and accessible.
• Keeps personnel updated on new document versions and how to obtain access.
• Controls prints and distributes documents as needed.
• Retrieves documents and records as needed.
• Ensures labeling/indexing consistency with naming/numbering system.
• Ensures readability and avoids deterioration.
• Handles records across departments to protect integrity.
• Establishes record retention timelines and maintains records accordingly.
• 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.
• Records keeping of deviations, investigations, change controls, CAPAs, etc.
• Verify lot numbers, serial numbers, UDI and primary labelling.
• Identify documentation gaps, correct errors, and track metrics like RFT and turnaround times.
• Undertakes tasks assigned by leaders as appropriate.
• Successful candidate will be provided on-the job training.

Skills

Attention to detail

Self-starter

Team player

Good communication

Education

Certificate/Diploma/Advanced Diploma in Chemical Engineering or Pharmaceutical Science

Tools

MS Office Suite

DMS

ERP

MES

Job description

Racer Technology Pte Ltd is seeking a document control specialist to oversee SOP quality, manage controlled documents, and maintain records for manufacturing and operations. The role requires adherence to cGMP/GDP standards with on-the-job training provided.

Responsibilities include reviewing records for compliance, maintaining DMS/ERP/MES data, labeling and indexing documents, retaining records on schedule, and ensuring accessibility. East area, Changi South.