Job Description
Master & Issuance of SOPs, Formats, Logbooks, GTP, STP, Specification & other documents
Preparation & Revision of SOP
Handling of Deviation, Incidence, OOS, and Investigation Failure
Handling of the change management system
Handling of the control sample
To fill raw data invalidation report
Participates in validation activities as per protocol
Management of stability sample & Preparation of Stability study protocol
Preparation of BMR, BFR & BPR
Preparation of MFR, Process validation protocol
Reporting of cleaning validation & process validation batches
Preparation of APQR & Risk assessment
Data & report compilation of Self-inspection
Handling & reporting a market complaint