QA Compliance Auditor
Bangalore, India
Job responsibilities:
– Conduct work as identified on the audit activity table (listing on table is not all inclusive but a representative sample)
– Development and delivery of training (to operational groups)
– Delivery of training in performance of audits (basic, intermediate audit activities)
– Provide advice and guidance on aspects of quality and compliance
– Provide consultation to the operational team on quality issues
– Cross-site QA and operational relationship, provide recommendations for improving compliance and/or efficiency
– Work with operational management to support Quality topics and/or working on projects with QA team on other sites [showing development of collaboration skills]
– Manage local Quality initiatives aimed at improving compliance and/or efficiency of the local QA organization
– Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed
– Other duties as assigned by management.
Minimum Required:
– 4 years in regulatory environment (experience in GXP roles)
– Experienced GxP auditor
– Able to influence QA strategy
– Ability to communicate to groups
– Knowledge of multiple operational areas
– Knowledge of industry quality systems/standards and ability to apply appropriate regulatory knowledge to multiple scenarios
Education:
Recommended:
– A minimum of a Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science experience)
– Experience may be substituted for education.
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