Job Description

Essential Duties and Responsibilities:

  • Maintains an updated list of quality agreements and alerts whenever required
  • Ensures integrity of information and data in documents.
  • Manages periodic review of documents, procedures and their impact assessment.
  • Assistance in providing training on documentation related processes and systems.
  • Communicating problems and suggesting workable solutions related to documentation.
  • Create and edit documents following guidelines as outlined in the division documentation SOPs (Standard Operating Procedures), GDP (Good Documentation Practices), and configuration manual.
  • Supports in preparing, processing and delivering Quality and R&D documentation to R&D department.
  • Create, Issue and control documents associated with R&I specification with minimal supervision.
  • Assist in providing training on documentation processes and systems.
  • Ensure appropriate documentation is complete, correct and that quality schedules are met.
  • Coordinate and support R&D employees in documentation related issues.
  • Understanding all required steps in the documentation process, identifying more efficient process(s) and updating the corresponding procedure(s) accordingly.
  • Supports quality activities during internal/external audit and other quality projects as needed.
  • Manages issuance and effectiveness of documents in TcU application.
  • Provides support on the preparation of the Site-Quality review as necessary.
  • Project management which includes managing change controls –using client's in-house quality systems like TW8 and TcU. 

 

Qualifications:

  • Demonstrate good organizational skills and prioritize multiple projects and tasks efficiently.
  • Must demonstrate effective communication skills, must be able to negotiate and resolve conflicts in an amicable manner for win-win situations for the impacted parties.
  • Good analytical skills to notice error(s) in documentation and to take appropriate corrective actions.
  • Fluency in English (both written and oral).
  • In-depth knowledge of document processing and data management.
  • Good command over Microsoft office tools (MS Word, MS Excel, MS PowerPoint, or SharePoint).
  • Have skills in effectively training R&D employees and supporting their activities.
  • Demonstrate responsiveness to customer needs within job scope.
  • Can work under minimal supervision.

 

Education and/or Experience:

Master’s in science/M. Pharm. /B. Tech with 3-5 years of quality, regulatory or combination of both in drugs/pharmaceutical and medical devices space. Must have worked in Quality Control lab and experience on testing of incoming raw materials and release of finished goods. Must have experience in creating product data sheets, incoming specifications and product specification documents.

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