Locations:
Mumbai
Experience:
3 – 7 years
Keywords / Skills :
Audit &Compliance, SOP, Pharmacy, CDM, Quality Assurance, Clinical Trials
Education:
B.Pharm, B.Sc, M.Pharm
Stream:
• Pharmacy
• Pharmacy
Function:
Pharmaceutical/ Biotechnology
Role:
• Clinical Research Associate/Manager
• Quality Assurance Manager
• Other Pharma – Audit & Compliance
Industry:
• Bio Technology & Life Sciences
• Chemicals/Petrochemicals
Summary:
Job Role: Data AnalystInspection Management , Audit Exposure , Risk Management , Deviation Management , Change Management , RCA/CAPA ManagementTraining of site personnel on SOPs.Call On :8106482255/[HIDDEN TEXT]
Posted On:
12th Jul 2016
Inspection Management , Audit Exposure , Risk Management , Deviation Management , Change Management , RCA/CAPA Management
· Quality System Training ,Quality Assurance Relationship (QAR) ,Audit Finding classification and Reporting Preparation of SOPs and understanding of quality check.(ICH GCP E6,E3)
· Assuring quality check of clinical trials documents in compliance with the sponsor, regulatory & SOP requirement.
· Training of site personnel on SOPs.
· Knowledge of ISO 9001:2008 requirement & hosting internal audits for the same.
· Preparation of site for regulatory/sponsor’s audits.
· Involved in Site Start Up, Initiation & Close out Audits for various clinical trials.
· Exposure.(MHRA/PMDA/GCP/FDA etc)
· Knowledge of CDM.
· Maintaining Trial Master File.
If interested please drop your resume to [HIDDEN TEXT]
:
Audit &ComplianceSOPPharmacyCDMQuality AssuranceClinical Trials
Advansoft International is an ERP Consulting, Implementation, Contract Staffing and an advanced Information Technology consulting firm with over 16 years of industry experience headquarter in Hyderabad, India and having global operations.
Advansoft focuses on verticals like KPO / BPO / IT / Insurance, Banking and Finance / Telecom and Retail Pharma / Sales.
Advansoft offers its clients end to end recruitment solutions tailor made to suit all kinds of manpower requirements.
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Advansoft International is an ERP Consulting, Implementation, Contract Staffing and an advanced Information Technology consulting firm with over 16 years of industry experience headquarter in Hyderabad, India and having global operations.
Advansoft focuses on verticals like KPO / BPO / IT / Insurance, Banking and Finance / Telecom and Retail Pharma / Sales.
Advansoft offers its clients end to end recruitment solutions tailor made to suit all kinds of manpower requirements.
Follow
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