Quality Sr Specialist-API

Role & responsibilities

• Responsible for Collection, compilation, analysis, and review of all data for APQR.
• Responsible for Processing and oversight of changes through the generation, justification, impact assessment, modification, review, approval, and implementation workflow.
• Responsible for Review/approval of all documentation associated with the process validation ,CPV & cleaning validation.
• Responsible for processing of documents through the generation, modification, review, and approval and archival of records.
• Responsible for review/approval of all documentation associated with the GMP equipment. This includes any Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documents.
• Responsible for tracking, trending, and reporting of Quality Metrics for site, regional, and global review. Trending as required by SOP, Corp. Standards, and/or regulations.
• Responsible for Review/approval of all documentation associated with the establishment and configuration of a GMP computerized system. This includes all lifecycle documents.
• Responsible for Review of regulatory and quality compliance requirements and divisional policy, performance of gap assessments, and establishment or improvement of SOPs covering all areas of applicability.
• Quality support to Regulatory Affairs as it relates to updates/changes to Market Authorizations.
• Responsible for Management, tracking, and/or performance of GMP type training supporting plant performance and Quality Departmental training and hands on qualification.
• Responsible for Review/approval of the Validation Master Plan and all documentation associated with the validation or qualification of a process, system, equipment, facility, and/or the utilities associated with the site.

Preferred candidate profile

• B.sc/Msc in chemistry
• 4 to 10 years of experience