Location
Bangalore | India
Job description
We are looking for a Compliance Analyst to join our team in India. This is an amazing opportunity to work on the Quality and Compliance aspects of all of Clarivate's GxP offerings in the Life Sciences and Academia & Government business lines. The team consists of 6 colleagues and is reporting to the V.P., Quality & Business Excellence. We have a great skill set in GxP Quality, regulatory compliance, computerized systems validation (CSV), ISO and other industry standards/best practices and we would love to speak with you if you have skills in assisting in the management and administration of the Quality Management function.
About You - experience, education, skills, and accomplishments
- Bachelor's degree, preferably in life sciences. Equivalent experience may be accepted in lieu of a degree.
- 1-3 years current experience authoring controlled Quality documents (e.g., SOPs, validation deliverables, GxP records, etc) within the pharmaceutical or life sciences industries
- 1-3 years current experience working in a GxP-regulated environment
- 1-3 years' experience authoring and/or reviewing formal Computer Systems Validation deliverables
- Familiarity with Good Documentation Practices and other essential quality management activities
- Must be familiar with US and EU life sciences and pharmaceutical regulations (including 21 CFR Part 11/Annex 11) and guidance
It would be great if you also had . . .
- Strong sense of professionalism and interpersonal, organizational, and communication skills, both verbal and written
- Proficient at problem-solving
- Ability to manage multiple tasks effectively & efficiently
What will you be doing in this role
- Working directly with members of Quality Management and other internal teams to ensure the accuracy and consistency of system development deliverables.
- Assisting with authorship and conduct of assigned activities related to computer systems Validation documentation. This includes, but is not limited to, Validation/Compliance Assessments, System Risk Assessments, 21 CFR Part 11 Assessments, Computer Validation Plans, Test Plans, Test Reports, Requirement Specifications, Release Memos and Validation Summary Reports.
- Authoring and/or reviewing other GxP records
- As directed, routing of documents through the electronic Quality Management System (eQMS) and overseeing collection of approvals
- Administration of the electronic Quality Management System (eQMS) by overseeing provisioning and removal of accounts for colleagues as part of onboarding/offboarding activities
- Engaging in ongoing user access review/controls to ensure compliance
About the Team
The team oversees the entire Quality Management System (QMS) with regard to our directly or indirectly GxP-regulated software offerings. We work closely with all other functions of the business, including (but not limited to) Technology/Development, IT/infrastructure, Risk Management office, Information Security, Operations, Finance, and Legal. The team currently consists of 6 deeply experienced Quality Management professionals, across geographies in the U.S., U.K., and India.
Hours of Work
Full time permanent flexible working hours as long as obligations are met
At Clarivate, we are committed to providing equal employment opportunities for all persons with respect to hiring, compensation, promotion, training and other terms, conditions and privileges of employment. We comply with applicable laws and regulations governing non-discrimination in all locations.
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