Job Description

Responsibilities:

• Process all Change Plan/Requests for creation or changing of site documents through the company Document Management System following applicable policies, process, and procedures
• Perform proofreading of documents and approve submitted to the Documentation Area for further processing in company Document Management System
• Identify and notify impact of submitted changes to existing procedures in current Document Management System or other quality system applications such as DCS, SAP, LIMS, MES / POMS, Delta V, Maximo, etc.
• Notify Training area on the document revision/creation or obsoleting
• Assign correct and accurate Effective and Periodic Review Dates to QS documents and specifications
• Request for Controlled Issuance of paper records (e.g. SOPs, protocols, forms) for execution (if required)
• Ensure synchronization between multiple document changes and multiple sites
• Maintain, organize, scan, and retain documentation in the defined area
• Responsible of Record Retention of IT area documents. Assure all controlled documents are retained according to company Policies and procedures
• Familiarize with the document management system
• Manage and organize the electronic and hardcopy documents in an orderly manner according to Standard Operating Procedures (SOPs) and policies requirements
• Oversee the update and distribution of IT documents
• Review the formatting and editing of documents according to guidelines and templates
• Help department route documents for revision and approval

• Identify opportunities and propose workflow improvement to improve efficiency

About You:

• Bachelor in Engineering, Sciences, Business, Information Systems or equivalent. 1-2 years of experience in documentation DMS/ QA in pharma or biotech facility. Fresh polytechnic graduates welcome to apply.
• Proven work experience as a Document Controller or similar role
• Knowledge of Electronic Document Management Systems (EDMS)
• Knowledge of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) in a pharma or biotech facility
• Good interpersonal, communication and presentation skills.
• Must be a self-starter, fast learner, curious with strong analytical and organizational skills
• Self-motivated and willingness to learn
• Reliable and Responsible

Only shortlisted candidates will be notified.Contract length: 6 Months. Option to extend depending on performance and business needs.Location: TuasJob Type: Contract
Contract length: 6 monthsSalary: $2,000.00 - $3,000.00 per monthCOVID-19 considerations:
All staff to observe MOH regulations and practicesEducation:

• Bachelor's or equivalent (Preferred)

Experience:

• documentation DMS/ QA in pharma or biotech facility: 1 year (Preferred)