QA/qc Reviewer
3 weeks ago
**JOB DESCRIPTION**: Professionals highly experienced in clinical research and well versed with all guidelines and regulations applicable to clinical research.
**QUALIFICATION**:
- Master’s degree in biotechnology/pharmacology/microbiology/Pharm D/Biochemistry
**ESSENTIAL FUNCTIONS**:
- Writing, review and coordination in the development of Standard Operating Procedures (SOPs)
- Distribution, monitoring and control of standard operating procedures within the organization
- Conducting quality control review of clinical trial documents such as the study protocol and clinical trial report
- Conducting clinical trial site audits
- Conducting internal company audits to ensure compliance with applicable standards, guidelines and regulations
- Developing Quality Management Plan for the company
- Organizing and conducting training programs on quality within the organization
- Communication skills and good interpersonal relationships.
**COMPETENCE**:
- Ability to work independently, coupled with management and organizational skills.
- Meticulous and detail oriented.
- Proficiency in the use of the Microsoft Office Suite and specialized software for electronic databases e-Clinical.
- Knowledge of the product under investigation for its mechanism of action, pharmacokinetics, and pharmacodynamics.
- Understanding of the regulatory context, good clinical practices and standard operating procedures
**Job Types**: Full-time, Regular / Permanent
**Salary**: ₹22,000.00 - ₹25,000.00 per month
Schedule:
- Fixed shift
**Experience**:
- Quality Assurance: 1 year (preferred)
- total work: 1 year (preferred)
Application Deadline: 15/02/2023
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