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Executive, Technical Writing at Amneal India

Ahmedabad, gujarat, India -

Full Time

Start Date

Immediate

Expiry Date

10 Jul, 26

Salary

0.0

Posted On

11 Apr, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Cleaning Validation, Process Validation, GMP Compliance, SOP Development, Risk Assessment, IQ/OQ/PQ Protocols, Data Analysis, Equipment Qualification, Regulatory Compliance, Documentation, TOC, HPLC, Swab/Rinse Recovery, Problem-solving, Analytical Skills, Cross-functional Collaboration

Industry

Pharmaceutical Manufacturing

Description

Purpose * Ensure that cleaning procedures and process validation activities are properly prepared, executed, and documented to maintain compliance with regulatory standards (e.g., GMP, FDA, EMA) and internal quality systems. * ?? Key Responsibilities * Cleaning Validation Activities * Develop and maintain cleaning SOPs and protocols. * Prepare cleaning schedules and ensure availability of required materials, equipment, and detergents. * Conduct risk assessments for cleaning procedures. * Coordinate with production teams to minimize downtime during cleaning. * Process Validation Support * Assist in drafting and reviewing validation protocols (IQ/OQ/PQ). * Collect and analyse data during validation runs. * Support qualification of equipment and utilities related to process & cleaning validation. * Ensure compliance with regulatory guidelines and internal validation master plan. * Documentation & Reporting * Maintain accurate records of cleaning and validation activities. * Prepare summary reports and deviations. * Provide all time supports in audits and inspections with providing documentation as required.

Responsibilities

The role involves developing and maintaining cleaning SOPs, protocols, and schedules while ensuring compliance with regulatory standards like GMP, FDA, and EMA. Additionally, the associate will support process validation activities, including drafting protocols, analyzing data, and coordinating with cross-functional teams.