Bharat Serums And Vaccines Limited MANAGER QA (CR&PV) Pharma
/ Biotech / Clinical Research
SOP conceptualization, review and amendments periodically
* Maintaining and monitoring SOP matrix applicable for local
and international Clinical trials
* Compliance of CR & PV as per currant ICH GCP, CDSCO GCP
and local & international regulations; Periodic Compliance report and
maintaining QMS
* Face inspections from regulatory authority/ partner/others
and provide compliance and CAPA towards closure of inspection by compliance
* Quality review board and periodic review meetings
* Conduct SOP training for department staff and maintain
training records
* Perform periodic GCP trainings
* Perform in-house audits to ensure that the all the in-house
activities are as per the SOP, GCP, and applicable regulatory requirements
* Perform audits at Investigational site to ensure that the
trial is conducted as per the approved protocol, GCP and applicable regulatory
requirements
* Participating in Regulatory Audits and providing compliance
to Audit Report.
* Ensure CT documents/BA-BE documents are scientifically
correct and meeting the applicable regulatory standards
* Identify the need for training in the department and plan
training for the CR & PV team members as and when required
* Perform root cause analysis and facilitate the smooth
functioning of the departmental activities
* Develop and maintain GCP/ICH compliant processes which
control the quality of work
* Participating in setting up and maintaining quality systems
that are compliant with applicable clinical regulations and standards
* Directly interface with clinical operation team to provide
vendor, site, and internal GCP audits
* Actively lead or assist activities in the areas of Internal
Quality Audits and suggest CAPA (Corrective and Preventive Actions)
* Lead auditing activities to ensure that studies are
conducted in accordance with protocols, GCP, and applicable regulatory requirements
* Lead and assist with identifying non-conformances with
requirements, provide suitable recommendations and facilitate ongoing quality
improvements while maintaining compliance with study protocols, and set
procedures
* Assisting with the clinical vendor qualification and
selection process
Salary: Not Disclosed by Recruiter
Industry:Pharma / Biotech / Clinical Research
Functional Area:Production, Manufacturing, Maintenance
Role Category:Production/Manufacturing/Maintenance
Role:Quality Assurance/Quality Control Manager
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