QA/qc Reviewer

3 weeks ago


Chennai, India SRM Institute of Science and Technology Full time

**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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