• Champions GMP requirements in both routine and non-routine operations.
• Perform batch review. Peform laboratory record /document review and approval according to company procedures and ensuring compliance to GMP standards.
• Review and approve lifecycle documentation associated with new or upgraded equipment, utilities and computerized systems.
• Serve as Quality Technical lead for qualification/validation-based activities to support the introduction new or upgraded equipment, utilities and computerized systems in line with current guidance and site/global procedures.
• Change Control/SOP review and approval.
• Deviation review and approval, issue resolution and CAPA monitoring.
• QA lead for root cause analysis and risk assessment activities.
• KPI data - monitor and evaluate trends, propose CAPAs to eliminate adverse trends
• Write and/or review and approve quarterly reports, trend reports, technical reports for QA and as QA project lead.
• Supplier Quality Management of clinical and commercial raw materials.
• Clinical & commercial Raw material & component release approval.
• Clinical & commercial laboratory documents review and approval.
• Internal & external lead auditor and on-site audit participation and management.
• Participation as QA lead in site and global project teams in line with strategic objectives.
• Interaction with clients/ project collaboration.
• Co-ordinate APR generation.
• Strong understanding of Pharmaceutical Regulation in own area and department.
• Competent in the use of electronic systems to support own role and departmental requirements.
• Competent in application of data integrity requirements.

• Five or more years of experience in the pharmaceutical quality function
• Thorough knowledge of FDA and EU cGMPs and pharmaceutical manufacturing requirements, specifically analytical requirements
• Thorough knowledge of GMP laboratory equipment and computer systems IQ/OQ/PQ requirements and data integrity needs
• Experience in pharmaceutical product development
• Broad quality experience, preferably including manufacturing operations, API and drug product specification, release, method development, method validation and transfer, stability, process validation.  
• Strong ability to troubleshoot and problem solve
• Experienced in Quality Management Systems
• Ability to effectively plan, organize and prioritize work

Education: 

Bachelor’s degree in a scientific discipline or related field required