Amneal Pharmaceuticals

Senior Officer, QC Technical Writer

Amneal Pharmaceuticals  •  State of Gujarāt, IN (Onsite)  •  8 hours ago
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Job Description

  • Prepare Stability Summary Reports (SSR) and related stability documentation.
  • Track stability study status, report timelines, and documentation activities.
  • Maintain stability records, reports, and supporting documents in an organized manner.
  • Review stability data and documentation for completeness and accuracy.
  • Coordinate with QC, QA, and cross-functional teams for data collection, review, and approval of SSRs.
  • Ensure timely updates, document revisions, and archival of stability documents.
  • Maintain documentation compliance as per GMP, GDP, and regulatory requirements.
  • Support audit and inspection requirements by providing stability documentation and records.

Required Skills:

  • Stability Documentation & SSR Preparation – Ability to prepare accurate and compliant Stability Summary Reports.
  • Document Tracking & Record Management – Strong skills in maintaining and monitoring stability documentation status.
  • GMP/GDP Documentation Practices – Understanding of regulated documentation requirements.
  • Data Review & Accuracy – Ability to verify stability data and ensure completeness of reports.
  • Coordination & Timeline Management – Effective follow-up with teams to ensure timely completion of stability documents.
Amneal Pharmaceuticals

About Amneal Pharmaceuticals

Amneal (NASDAQ: AMRX) is rapidly becoming one of the most dynamic, purpose-driven pharmaceutical companies delivering more affordable access to essential medicines. Our family delivers for yours through a robust U.S. generics business, a growing branded business and deepening portfolios in injectables, biosimilars and select international markets. We’ve bolstered our world-class scientific rigor, production capabilities and commercial infrastructure. And we invest substantially in our people through leadership development and employee well-being programs – all so we can deliver even more value. We are Amneal and We make healthy possible.

Content is for informational purposes only and 3rd party content does not reflect Amneal’s opinions.

Amneal has the right to remove comments that violate another’s copyright or intellectual property, mention an Amneal product, use profanity or are defamatory, promote and solicit for third-party sites, initiatives, or products, or are factually inaccurate or misleading or spam.

Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or drugsafety@amneal.com. If you are currently experiencing a life-threatening event, please immediately contact 911.

Industry
Chemicals & Materials
Company Size
5,001-10,000 employees
Headquarters
Bridgewater, New Jersey
Year Founded
2002
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