Quality Assurance
3 weeks ago
From 8 to 12 year(s) of experience
₹ 10,00,000 - 15,00,000 P.A.
- Mumbai (All Areas)
**Roles and Responsibilities**
- 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
- Perform root cause analysis and facilitate the smooth functioning of the departmental activities
- 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
- Conduct vendor audits and prepare audit reports
- Ensure proper maintenance of the clinical documentation database and system
- Keep up to date with all related quality legislation and compliance issues
- Quality review of CT documents, regulatory submission dossier,etc
- Perform periodic GCP trainings
Key Skills
- root cause analysisclinical researchDossierQuality Assurance
- Protocolsclinical documentationCompliancequality legislationregulatory requirementsquality systemsGCPSOPvendor audit
- Skills highlighted with ‘‘ are preferred keyskills
Education
- PG:_M.Pharma in Any Specialization
**Company Profile**:
NMS Consultant
Leading pharmaceutical Company
- Company Info
**Salary**:
10,00,000 - 15,00,000 P.A.
Industry:
Pharmaceutical & Life Sciences
Department:
Quality Assurance
Role Category:
Quality Assurance - Other
Role:
Quality Assurance - Other
Employment Type:
Full Time, Permanent
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