Intas Pharmaceuticals, SEZ Ahmedabad Job Opening

Intas Pharmaceuticals, SEZ Ahmedabad Job opening for Quality Assurance - QMS

Position SR.OFFICER – SR.EXECUTIVE

Experience – 4 –9 Years

Education – B.PHARMA / M.PHARMACY

Employment Type: Full Time, Permanent

Department QUALITY ASSURANCE - QMS

Job Location - Ahmedabad (Gujarat) CHANGODAR.

Note : candidates should apply resume with mentioned subject code: . OOS / OOT 10, CRF 10, Deviation - 10

Job Description

Handling of QMS related activities like change request form, Market complaint, Deviation, CAPA and investigation.
Co-ordination and handling of QMS activities in software, monitoring and closing of action plans within the timeline and effectiveness evaluation.
Handling and co-ordination of deviation and to perform the investigation/ Risk Assessment and assigning of CAPA.
To perform the investigation triggered from Market complaint, ADE, Deviation, Out of Specification (OOS), OOT (Out of Trend), Out of Calibration etc. in software.
Preparation of market complaint/ADE, deviations, change request and CAPA review summery.
To prepare and co-ordinate investigation study and execution of protocol. & Co-ordination for Quality Review Steering Committee and handling of CAPA initiation from the outcome.
Co-ordination for Self Inspection activity i.e. preparation of schedule, Audit planning, Audit Report and Compliance and CAPA.
To perform the risk assessment related to process, facility, equipment etc. in co-ordination with cross-functional team members.
To review the executed BPCRs and other related documents in relation to deviation, investigation and market complaints.