JD for Documentation Executive (1 Position)

Hands-on experience in QMS documentation

SOP preparation by covering all the aspects of guidelines.

Experience in Technology transfer and validations (Manufacturing and Analytical)

In-depth knowledge of guidelines.

GMP auditing experience. - like an internal and external auditor

Should have contributed directly to Regulatory Audits.

Understanding of GMP requirements and documentation for the contract manufacturing/outsourcing of manufacturing.

Review and approve vendor qualification documentation, Quality, and technical agreements.

Review of QMS documents, performing risk assessments involving regulatory impacts. (Eg. Change control, Deviations, OOS, complaints, SMF, site layouts, etc.)

Involvement in approval of outside agencies for technical and scientific services

To participate in Self-inspection, Internal audits.

To facilitate, coordinate and participate in training.

Experience: 1-2 Years,

Location: Nelamnagala,

Salary: 25 to 30k