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Amneal Pharmaceuticals
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Senior Executive, Technical Writing

Senior Executive, Technical Writing

Amneal Pharmaceuticals

3 - 7 years

0 Lacs

ahmedabad gujarat

Posted:5 days ago| Platform: Shine logo

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Skills Required

psp psr cleaning validation matrix cvp manufacturing packaging mpr sop ppqp ppqr cpvp bbhs cvsr cvrs pbr mps technical assessment deviations investigations

Work Mode

On-site

Job Type

Full Time

Job Description

As a Document Specialist, your primary role will be to work in collaboration with US team members to create high-quality documents and ensure timely delivery of outputs consistently. Your key responsibilities will include: - Preparing and reviewing PPQP, PPQR, PSP, PSR, CPVP, BBHS, and regulatory modules for submission/validation batches. - Creating and reviewing Cleaning Validation documents such as Matrix, CVP, CVSR & CVRs, and monitoring the Annual Cleaning Verification Program, DEHT & CEHT. - Handling CC, UD, PD, Event, and Customer complaints as needed. - Preparing and reviewing documents for manufacturing and packaging activities, including MPR, PBR, MPS, SOP, and other related documents. - Generating technical assessment reports and conducting deviations investigations. Qualifications required for this role include a degree in B.Pharma, M.Pharma, B.Sc., or M.Sc. Please note that Amneal is an equal opportunity employer that values diversity and inclusion. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in creating a workplace where everyone feels respected and valued.,

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Senior Executive, Technical Writing