PurposeTo review / approve Developmental Quality Assurance Documents
Position / Job TitleSenior officer
DepartmentDQA
Reporting ToSection Head
LocationThane
Years of Experience2 7 years
Dosage FormKnow-how of All dosage form
Job Responsibilities / DeliverablesTechnology transfer Dossier review
- To review the relevant documents which will be a part of TTD Below is the list of documents but not limited to: Raw Material specifications, Packing Material specifications, In process Material specifications, Finished product specifications. Standard testing procedures of RM, PM and FP. All stability protocols, Hold time study protocol and Additional testing protocols. Master Formula card, Master packing card BMR review and BPR review,
- To participate in the TTD meetings and review and approval of TTD documents on need basis
Quality management systems.
- Review of Lab investigations and non-conformances
- Document archival
- Preparation of SOP s
Qualification of Equipment.
- Review and approval of qualification documents including protocols and reports
Facility round
- Rounds of R & D facility, stability areas, Analytical development laboratory to ensure compliance
- To check the R & D data and integrity hard copy (including LNB) and soft copy
Qualifications & Pre-Requisites
Must-Have Skills
- Working in R&D setup either in formulation or analytical development
- Exposure to specific dosage forms like OSD, Liquid Orals
- Team coordination and work distribution
Additional notes
- Expected to work in all shifts.
- Will have to handle any other responsibility if allocated.
