Senior Executive, Technical Writing

Amneal Pharmaceuticals

0 years

0 Lacs

ahmedabad gujarat india

Posted:1 week ago| Platform:

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Skills Required

writing collaboration addition monitoring verification manufacturing packaging assessment reports diversity

Work Mode

On-site

Job Type

Full Time

Job Description

To work in collaboration with US team members to create the highest quality documents and timely delivery of outputs consistently.
Prepare and review PPQP, PPQR, PSP, PSR, CPVP, BBHS, regulatory modules (for submission/validation batches).
Prepare and review Cleaning Validation documents (Matrix, CVP, CVSR & CVR’s) in addition to timely monitoring of Annual Cleaning Verification Program, DEHT & CEHT.
Handling of CC, UD, PD, Event and Customer complaints as and when required.
To prepare and review documents for manufacturing and packaging activities which includes but not limited to MPR, PBR, MPS, SOP and other manufacturing and packaging related documents.
Prepares technical assessment reports and deviations investigations, etc.

Qualifications

B.Pharma/M.Pharma/B.Sc./M.Sc.

About Us

Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.

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