Quality Assurance

2 days ago

Mumbai, India NMS Consultant Full time

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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