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QA Training Specialist I/II - job post

NexPro Technologies Inc
Remote
₹35,000 - ₹55,000 a month

Job details

Here’s how the job details align with your profile.

Pay

  • ₹35,000 - ₹55,000 a month

Job type

  • Full-time

Shift and schedule

  • Monday to Friday

Benefits
Pulled from the full job description

  • Work from home

Full job description

QA Training Specialist I/II

Job Summary

The document control specialist is responsible for administering the processes and practices which support documentation compliance.

The Specialist will work in a GXP environment with a key-focus on documentation accuracy, quality and integrity.

Reports to: QA Head

Essential Functions / Responsibilities

  • Manage document control processes through electronic systems and/ or paper based systems and processes. Distribute approved documentation to appropriate personnel, track receipt of documentation and
  • Maintaining lists and postings required for both electronic and hard copy; maintain specific databases in Document Control Department and training records.
  • Perform data entry and management in systems (Document Compliance and Process Compliance) and maintain the print/soft copies for all documents.
  • Collaborate with teams to complete, maintain an up-to-date Document Control Systems.
  • Store, archive, and retrieve the version documents such as certificate of analysis of materials and products, specifications, methods, protocols, and report files.
  • May need to assist with and author relevant SOPs, methods and protocols, and other controlled documents.
  • Distribute approved documentation to appropriate personnel, track receipt of documentation.

Ensure that documentation and corporate records adhere to all applicable legal, clinical, financial, and regulatory requirements

Coordinate and track document approvals and any related activities and ensure on-line documents are updated and accurate.

  • Work with other departments to clarify and correct documentation to ensure compliance.
  • Organize and maintain the work area and keep up-to-date files Additional Responsibilities Prepare documentation for third party inspection/audits.
  • Assist validation and regulatory department for documentation and for their various requirements.

Qualifications / Experience / Education

Education

  • Bachelor’s Degree required at a minimum.

Preferred Work Experience

  • Highly preferred 2 or more years of GXP Systems Experience in a QA Documentation Role
  • Highly Preferred Previous experience with EDMS (Electronic Document Management Systems) Administration and Set up in a GXP Environment i.e. with Pharma, Med Device or GXP Systems Providers
  • cGMP and computer skills (MS Word, Access and Excel) - Advanced
  • Multitasking and flexibility to accommodate changing priorities.

Job Type: Full-time

Pay: ₹35,000.00 - ₹55,000.00 per month

Benefits:

  • Work from home

Schedule:

  • Monday to Friday

Experience:

  • total work: 1 year (Preferred)

Work Location: Remote

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