Executive to Asst Manager- QA /QC
- Handled QMS documentation-document control, deviation, change control, out of specification, CAPA and Quality Risk Assessment and Management.
- Supervision of the routine inspection and audits
- Oversight & spot-checks of the quality production, packaging, quality control, engineering and warehouse.
- Ability to written and review of procedures & documents (protocol / reports/ VMP/ SMF/ BMR/ SOP/ COA/log books/artworks/ Specification and STP)
- Handling, investigation of change control, deviation, OOS /OOT/ Market complaints.
- Handling CAPA, NCR, Deviation, Change Control, Log Books etc
- Handling and knowledge of GMP guidelines/ SOP.
- Knowledge and handling of Utilities Validation-HVAC System, Water System, Boiler System, Compressed Air System, Effluent Treatment System.
- Trending of data (handling of APQR/ Stability data trending)
- Knowledge of Equipments / Instruments Qualification and validation.
- Knowledge of Instruments / equipment calibration.
- Artwork handling/ SAP handling
- Knowledge of AMV (Analytical / Microbial).
Sr. QC Officer
QC Officer
- Knowledge and handling of HPLC/ FTIR/ Dissolution instrument etc.
- Handling of QC instrument calibration/ qualification.
- Handling of Reference standard/ working standard/ primary standard.
- Preparation of departmental SOP/Specification and STP.
- Knowledge of chemical and instrumental analysis for RM/PM.
- Knowledge of Good Laboratory practices / GDP/ QMS/ AMV.
5+ years experience
Email: versha@mankindpharma.com
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