Position: Associate Consultant – QA
No of position: 1
Job Location: Pan India
Responsibilities
- Interpret, build upon, and comply with organization’s quality assurance standards
- Implement quality assurance policies and procedures applicable to the organization’s need
- Plan, conduct and monitor product quality and process efficiency
- Coordinate internal audits and support audits conducted by clients
- Coordinate investigation of customer complaints and non-conformance issues
- Ability to develop, recommend, and monitor corrective and preventive actions
- Prepare reports to communicate outcomes of quality activities
- Assure ongoing compliance with quality and industry regulatory requirements
- QA consultant for CSV activities & release in accordance with organization’s policies. For example:
- Author/review of key validation documents like VP, Change Request, Risk Assessment, Trace Matrix, Validation Summary.
- Testing: Author/Review/Execution of IQ, OQ, PQ
- Test Defect Management
Technical Skills
- 1-3 years of experience in QA (in Pharmacovigilance preferable)
- Experience in Quality Management Standards like ISO 9001
- Experience in Software Quality Assurance
- Experience in Computer System Validation (CSV)
- Good knowledge of CSV principles like GAMP, PIC/S
- Good knowledge of various regulatory requirements like US FDA, EU, MHRA etc. for CSV and Quality Assurance.
- Good knowledge of Software Development Life Cycle
Soft Skills and Competencies
- Must have good written & oral communication skills.
- Strong analytical and problem-solving skills
- Good decision-making skills and customer focus
- Great team player with the ability to work with minimal supervision
Education
- B.E /B. Tech/ MCA/B. Pharm/M. Pharm or any related bachelor’s degree