Position: Research Associate - II
Department: QA (Quality Assurance)
Qualification: MSC, B. Pharm, M. Pharm
Experience: 01 to 03+ year's
No Vacancy: 03
Note: Immediate joiner preferred
Job Location: Shivajinagar, Wakadewadi Pune.
Responsibilities:
Review MV protocol, study protocol, SOP and retrospective raw data and Bioanalytical reports as per regulatory guidelines, in house SOP's and Protocol.
Plan and conduct in process audit of various Bioanalytical phases.
Plan and conduct system audit of various section of Bioanalytical Research Department, General administration department and Project Management and Biopharmaceutics department as per the schedule, prepare audit report and ensure compliance for the same.
Plan and conduct vendor audit of various vendor/ service provider as per schedule and prepare audit report.
Train QA auditors and others on in house SOP's / system.
Review validation and calibration reports of the instrument/equipment of all departments for compliance.
Issue, distribution and reconciliation of SOP, Forms and logbook.
Synergen Bio Private Limited was founded by a group of passionate professionals with a vision to establish a premium Clinical Research Organization known for its Quality, Knowledge, and Expertise. Synergen Bio Private Limited is a DCGI(CDSCO) approved new age CRO with all necessary infrastructure to serve the Pharmaceutical and Biotech industry.
Synergen Bio recognises the value of high-quality clinical research services and works to offer them to our sponsors at significant cost savings because to our teams extensive experience. We provide specialised solutions to meet sponsor requirements for the whole range of clinical research as a vertically integrated CRO.