Documentation Quality Assurance /DQA/Assistant Manager

Job Description

Role & responsibilities Preferred candidate profile 1. Responsible for the Change control Handling through Track wise related to Spec & STP & CAPA 2. Prepare the Specification & Standard testing procedure of API Site. 3. Review of Method of analysis (MOA), Specification, STP of RM, IM, PM, INP, API & Cleaning generated by R&D Analytical. 4. Review of Standard qualification COA. 5. Review of Method comparison & MOA with Pre-validation data 6. Review of Validation Protocol & validation Report with respect to analytical data and Journal. 7. Review of R&D batches Stability data. 8. Issuance, login and closing of Incidence and change control of DQA/R&D-synthesis/R&D-Analytical. 9. Issuance of format, Logbooks, BMR and uncontrolled copy of MOA and/or Spec & STP. 10. Document and data control i.e. Receiving, Issuance/Distribution, Archival, Control, Storage and destruction of documents. 11. Assigning analytical method validation protocol and Report Numbering. 12. Responsible for sample management activity (i.e. Receiving, Issuance and Discard)