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Job Description
- Manages and process DCRs, SOP’s. Track revision history.
- Maintains files and data archiving of controlled QA documents.
- Maintains documents in accordance with department SOP’s - Analyzes all documents to ensure that controls regarding format and content are incorporated.
- Maintains database of information including all document numbers, dates and distribution requirements. Generates logs, indexes and distribution lists as required. Assures that all documents are reviewed for continuing compliance to cGMP’s and company policies on a periodic basis.
- Processes change control activities includes assigning tracking numbers, routing, tracking, and expediting change control, distributing new documents and retrieving obsolete ones, performing changes to text documents, and reporting on change control status to management.
- Maintains Quality documents, including, but not limited to, Reports, Batch Records (MBR), DCRs, training, test methods, forms and other supporting documents.
- Issues, but not limited to, batch records, logs, forms and other documents as requested or as scheduled.
- Tracks the issuance of deviations, CAPAs, NCMRs, OOS, Complaints and doing the Data analysis
- Coordinates in-house training for new and revised documents as required. Maintains hardcopies and electronic database of all employee training records.
- Ensures daily work flow completion by conducting internal audits and assist in external audits
Job Requirements
- Bachelor of Business Administration / quality section preferred
- Experience from 3 to 6 years As Quality Assurance
- Knowledge of controlled document system required, ISO, cGMP’s preferred
Competencies :
- Problem solving
- Follow up & Organization
- Communication skills
- Team work
- Data analysis
