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Excellent job opportunity for a Clinical QA .

Keywords / Skills : Clinical QA, Troubleshoot , cGMP audits, Quality management , QA, Quality Assurance Analyst, Quality Analyst

3 - 5 years
Posted: 2019-07-29

Nationality
India
Industry
Bio Technology & Life Sciences
Hospitals/Healthcare/Diagnostics
Function
Health Care
Pharmaceutical/Biotechnology
Role
Quality Control Manager
Quality Assurance Manager
Other Pharma
Education
Master of Pharmacy (MPharm)
Stream:
Pharmacy
Salary
5.60 - 6.70 lacs
Posted On
29th Jul 2019
Job Description
• Ensure that all processes contributing to the performance of a clinical trial are conducted properly.

• Troubleshoot clinical trials and activities.

• Plans and conducts cGMP audits of manufacturing facility, GCP audits at investigator sites and CROs, GLP audits at CROs for pre-clinical toxicology and efficacy studies.

• Conduct audits of clinical trial documents, including Investigators brochure, clinical protocols, and Clinical Study Reports, Case Report Forms, and informed consent forms.

• Ensure clinical trials are performed in accordance with applicable study protocols and in compliance with GCP guidelines.

• Writing and reviewing Clinical SOPs and other quality documents

• Vendor / supplier qualification in co-ordination with cross functional departments.

• Lead internal auditor for ISO 9001:2008 audit, identification of non-conformances, root cause analysis and suggesting appropriate CAPA for the closure of audit points.

• Conducting Quality management review meeting to reach the organization goals incompliance with current regulatory requirements.

• Manage and maintain databases for the quality system.

• Prepare and assist in preparing annual reports and quality trending reports.

• Report the status of the quality levels of staff, systems and production activities.

• Preside over improvement programs.

• Evaluate quality events, incidents, queries, and complaints.

• Keep up to date with all related quality legislation and compliance issues

• Compile and prepare materials for submission to regulatory agencies.

• Document internal regulatory processes.

• Ensure regulatory rules are communicated through corporate policies and procedures.

• Utilize guidance documents, international standards, or consensus standards and interpret for guidance.

• Ensure that investigator, vendor, facility and system audits are conducted.

• Communicate any critical compliance risks noted from these activities to senior management.



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Medical
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