Senior Executive, Technical Writing Amneal Pharmaceuticals

3.0 - 7.0 years

0 Lacs

ahmedabad, gujarat

On-site

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 documen...

Posted 5 days ago

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Senior Executive, Technical Writing Amneal Pharmaceuticals

0.0 years

0 Lacs

ahmedabad, gujarat, india

On-site

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 ...

Posted 1 week ago

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