Roles and Responsibilities
- To ensure proper Planning & Timely Release Of raw Material, Packing material in Process samples, Bulk & Finished Product, Validation Samples, and Water Samples & Stability Samples
- To ensure that Approved Specification & Testing Method available for Raw Material, Packing Material, Bulk Product and Finished Product, stability Of the Product.
- To ensure that all the analysts are Trained & Qualified on the jobs they are doing
- To arrange internal Training Program as per The Schedule
- To ensure that all the Instruments are qualified & periodically Calibrated as per schedule.
- To ensure that Laboratory Is GLP/Schedule L1 Compliant.
- To ensure Deep Investigation Of laboratory Incident, OOS, OOT, OOE is done & CAPA is taken To avoid Reoccurrence.
- To ensure that GDP is followed in the laboratory without any data integrity issue.
- To Review the SOPs, SPC, STP and other GLP/GDP related Documents.
- To review the validation & Equipment Qualification Protocol.
- To ensure Planned and economical utilization of Reagents with up to date Records and safe Handling Of equipment's and Apparatus.
- Inventory control of reference samples of Raw material and packaging material
- Planning of Analytical Method Validation and Analytical Method Transfer activities.
- Product Knowledge
Employement Category:Employement Type:
Pharma / Biotech Role Category:
Quality (QA-QC)Pharmacist / Medical Representative Functional Area:
Qc & QA Executive