Senior Executive, Technical Writing

Amneal Pharmaceuticals LLC; India; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Amneal Pharmaceuticals LLC seeks a dedicated professional for Manufacturing Process Operations in Ahmedabad, Gujarat. Responsibilities include coordinating with the US team, updating databases for operations and packaging, and ensuring timely delivery of high-quality documents and outputs.

The role requires preparing and reviewing regulatory modules and cleaning validation documents, handling complaints, and producing technical assessment reports and deviation investigations.

Qualifications

• Coordination with teams and stakeholders.
• Document preparation and review for quality compliance.
• Strong understanding of regulatory documentation and submissions.

Responsibilities

• Coordinate with US team on routine tasks.
• Update required status and databases for Operations and Packaging.
• Collaborate to create high quality documents and timely outputs.
• Prepare/review PPQP, PPQR, PSP, PSR, CPVP, BBHS, regulatory modules.

Skills

Coordination

Documentation

Regulatory affairs

Education

B.Sc./ B.Pharm/ M.Sc./ M.Pharm

Job description

Co-ordination and communication on routinely basis with US team.

Updation of required status and database for Operations, Packaging, MST/ Technical Services .

To work in collaboration with 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, LOTC, DEHT & CEHT.

Handling of CC, UD, PD, Event and Customer complaints as and when required.

To prepare and review documents for manufacturing activities which includes but not limited to MPR, PBR, MPS, SOP and other manufacturing related documents.

Prepares technical assessment reports and deviations investigations, etc.

Qualifications

B.Sc./ B.Pharm/ M.Sc./ M.Pharm

Job Info

• Job Identification 7701
• Job Category Manufacturing Process Operations
• Locations Shapath-V, Near Hotel Crown Plaza, Ahmedabad, Gujarat, 380015, IN