Quality Assurance Documentation Specialist

0 - 2 years

0 Lacs

Posted:2 weeks ago| Platform: Indeed logo

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Work Mode

On-site

Job Type

Full Time

Job Description

About Us:

Fido Pharma is a leading pharmaceutical manufacturer committed to ensuring the highest standards of product quality, safety, and compliance. We are currently seeking a highly organized and detail-oriented Quality Assurance Documentation Specialist to join our Quality team.

Job Summary

The QA Documentation Specialist is responsible for managing, reviewing, and maintaining controlled documents to ensure compliance with GMP (Good Manufacturing Practices), company policies, and applicable regulatory requirements. This role plays a critical part in ensuring that our products meet the highest quality standards through proper documentation practices.

Key Responsibilities

  • Maintain and control Quality Assurance documentation including SOPs, protocols, batch records, specifications, reports, and training records.
  • Assist in the preparation, revision, issuance, and archiving of controlled documents.
  • Ensure documents are accurate, up-to-date, properly formatted, and comply with internal and regulatory standards.
  • Support document change control processes and maintain document lifecycle tracking.
  • Coordinate with cross-functional departments to ensure timely review and approval of documents.
  • Assist in internal and external audits by preparing documentation and supporting audit readiness.
  • Maintain electronic document management systems (EDMS), if applicable.
  • Ensure proper filing and secure storage of all QA records and documents.

Qualifications

  • Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or a related field.
  • 2-5 years of experience in a QA documentation or regulatory documentation role within the pharmaceutical, biotech, or medical device industry.
  • Knowledge of GMP, GDP, and relevant regulatory guidelines (e.g., FDA, EMA, ICH).
  • Proficiency in MS Office (Word, Excel, Outlook); experience with EDMS or QMS software is a plus.
  • Excellent written and verbal communication skills.
  • Strong attention to detail and organizational skills.
  • Ability to manage multiple tasks and deadlines effectively.

Why Join Us?

  • Competitive salary and benefits package
  • Opportunity to work in a growth-driven, innovative environment
  • Supportive team and leadership
  • Ongoing training and professional development opportunities

How to Apply:
Send your resume to hrd@fidopharma.com

Job Type: Full-time

Benefits:

  • Cell phone reimbursement
  • Health insurance
  • Provident Fund

Ability to commute/relocate:

  • Panchkula, Haryana: Reliably commute or planning to relocate before starting work (Required)

Experience:

  • Document management: 2 years (Required)

Work Location: In person

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