Position: Clinical QC- Manager
Qualification: MSC, B. Pharm, M. Pharm
Experience: 06 to 10+ year’s
No Vacancy: 01
Note: Immediate joiner preferred
Job Location: Shivajinagar, Wakadewadi Pune.
Responsibilities:
1. Preparation and Review of Clinical SOP for adequacy, correctness and completeness
2. Preparation of Checklist for Quality Control Audits
3. To Conduct SOP Training, suggesting modification in the current process to improve quality and to minimize the errors
4. To prepare plan and conduct in process audit of various Clinical phases like Registration, Screening, ICD Distribution, ICD Presentation & Obtaining. Medical Examination. Breath/Urine Alcohol Test and Urine screen for Drug of Abuse, check-in, Pre-dose vital examination, Dosing. Blood Sample Collection, Protocol Restrictions, Meal, Sample Processing & Storage, Vital Examination and Check-out, Ambulatory sample collection etc.
5. Retrospective review of Clinical Study Documents like Screening Records, Study CRF, Informed Consent Document, Medical Reports and Source Documents etc..
6. Plan and conduct audit of various section of Clinical Research Department (like Screening, ICU, Housing, Sample Processing & Storage) to ensure Regulatory, SOP & Protocol compliance.
7. To prepare audit reports and forward the audit observations to Clinical department Head/PI
8. To track instrument calibration schedule and preventive maintenance schedule and records.
9. Preparation of Sponsor Audit and Preparation of Regulatory Inspection
Interested Candidate Share CV on careers@synergenbio.com
