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Senior Officer, QC Technical Writer at Amneal India

Ahmedabad, gujarat, India -

Full Time

Start Date

Immediate

Expiry Date

19 Oct, 26

Salary

0.0

Posted On

21 Jul, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Stability Documentation, SSR Preparation, Document Tracking, Record Management, GMP, GDP, Data Review, Timeline Management

Industry

Pharmaceutical Manufacturing

Description

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.

Responsibilities

Responsible for preparing Stability Summary Reports (SSR) and maintaining organized stability records. Coordinates with QC, QA, and cross-functional teams to ensure documentation compliance with GMP and GDP standards.