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GCP Auditor
eClinical Solutions
posted 1hr ago
Job Role Insights
Fixed timing
Key skills for the job
Job Description
- Client Audit Hosting and Internal Audit activities, including follow up on the resulting actions
- Complete Internal audit activities related to Delivery and Process audits
- Ownership of managing the Quality Management System process gaps and needed improvements focused on the Services Organization which can be internally driven or a result of audit feedback
- Work collaboratively across various functional organizations including India Operations
- Inform senior management of any non-compliance incidents or regulatory compliance issues, which may arise internally or from external customers
- Remain abreast of and apply updates to regulations, guidelines, and principles related to Good Clinical Practice and provide advice on their use and compliance
- Work with company compliance experts by identifying quality issues and trends across various functional departments and establishing action plans for resolution
- Assist in the review and approval of QMS procedures
- Other duties as assigned
Take the first step towards your dream career. Here is what we are looking for in this role.
Qualifications:
- Bachelor s degree or equivalent work experience preferred
- 5+ years Pharmaceutical/Biotechnology industry or equivalent experience preferred
- 3+ years of experience, ideally from a GCP Quality or Operational role within a Pharmaceutical, Biotech company or a CRO preferred
- Certified Quality Auditor Certification or equivalent experience preferred
- Experience drafting, editing, and reviewing GCP SOPs and WIs
- Experience maintaining a QMS for the management of controlled documents, training, deviation, CAPA and audit management is a strong plus
Employment Type: Full Time, Permanent
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Strict timing
Monday to Friday
No travel
Day Shift
eClinical Solutions Benefits
Team Outings 
Work From Home 
Health Insurance 
Education Assistance 
Soft Skill Training 
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