SIRO Clinpharm Pvt. Ltd Released Job Openings On 14/12/2022.Siro Clinpharm is a drug development solutions provider to the global healthcare industry. Our subject expertise gives us an edge in clinical trial management, clinical data management, medical writing, biostatistics & statistical programming & pharmacovigilance. In 1996 Dr.Gautam Daftary founded SIRO in Mumbai, India. In 2001 company started providing its services in Data Management.
Vacancy Details:
SIRO Clinpharm Pvt. Ltd Recruiting Any Graduate Candidates with 03+ years of experience for Clinical Quality Assurance Position.Complete Details for the Clinical Quality Assurance as follows.
Important Details :
- Location :Hybrid
- No of Vacancies:NA
- Details of Salary: NA
- Opening date for online Application: 14/12/2022
- Mode of application :Online
- How To Apply: Please share CV – krishnaveni.thevar@siroclinpharm.com
Job Description/Skills Required
- Conduct the following audits either independently or as a co-auditor: Internal/ Contracted/ Standalone Audits, Audits of the Trial Master File, Database, Data Master File, Biostatistics and Programming, Clinical Trial Supplies, Investigator Site, Process, Bioavailability or bioequivalence clinical trials/ facilities, vendors, clinical laboratories.
- Clinical Trial Supplies Services Oversight
- In relation to Equipment Commissioning, Prepare performance qualification protocol/ protocol template; provide training on the performance qualification protocol.
- Management and distribution of procedures • Write, review and approve procedures • Support in distribution of procedures within SIRO and to clients • Support in maintaining controlled paper and copies of procedures • Support in maintaining a list of Current and Obsolete procedures •
- For inspections of SIRO, maintain Inspection Files, to contain the following documentation in paper and electronic forms, as required: Inspection correspondence, inspection proceeding notes questions asked to SIRO staff and answers provided, inspection findings, if any, action taken on inspection findings, if any.
- Conduct trend analysis of the audit observations to identify process gaps
- Host External Audits and Inspections of SIRO as assigned
- Perform QA Review of Clinical Study Documents Perform a review of the clinical study documents,
- Installation qualification, operational qualification and performance qualification documents, Change control documents etc. as per requirement of SOP/ LOV
- Compliance support wherever needed
- Ensure audit readiness and participate as required
- Training coordinator responsibilities: a. Develop Standard Training Plan and Record (STPR) i.e. role-based trainings in LMS for each designation in the department. Ensure colleagues complete required training within stipulated time by generating Compliance Reports’ to ensure compliance within the department.
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