Compliance Specialist

at  Piramal Pharma Solutions

EDUCATION

• Bachelor’s degree in a scientific discipline or equivalent

EXPERIENCE

• 4+ years of QA, Quality Systems, and/or Compliance experience in a cGMP/FDA regulated environment
• Sterile manufacturing of injectibles preferred
• Experience as a system / process owner for Quality Systems, including development and maintenance of performance metrics and internal customer support preferred

FUNCTIONAL AND TECHNICAL SKILLS

• Working knowledge of cGMP regulations, guidance, and general compliance expectations.
• Working knowledge of investigational techniques, including but not limited to root cause analysis, risk assessment, impact evaluation, and technical report writing.
• Must be a detail oriented team player with effective planning, analytical thinking, organization, and execution skills
• Must have basic proficiency in the Microsoft Office Suite, with moderate expertise in Excel
• Excellent communication skills with internal and external personnel is essential.
• Ability to work effectively at a fast pace with cross-functional departments and manage priorities to meet timelines
• Must be Innovative, proactive, resourceful and committed to continuous improvement
• Working knowledge of cGMP data management systems (EDMS, Trackwise, and/or SAP) is preferred

• Provide support and coordination for compliance-related projects
• Act as a primary point of contact for Supplier Quality Management
• Oversee review of corporate quality assessments of FDA observations (483s, Warning Letters) for their applicability to PPS-Lexington processes and procedures
• Develop and maintain quality system performance metrics for site and corporate management
• Provide support and documentation as necessary for client regulatory filings, annual product review activities, and health authority inspection responses
• Interact with clients and internal customers regarding compliance issues
• Create, prepare and review technical reports
• Act as the PPS-Lexington Data Integrity Coordinator
• Support site Quality Management Review process and reporting
• Apply cGMP (Current Good Manufacturing Practice) concepts into quality system documentation review, and development and/or modification of quality systems and other cGMP processes.
• Act as backup Change Control System / Process owner, including metrics, review/approval, and oversight activities
• Act as CAPA System / Process owner, including metrics, review/approval, and oversight activities
• Act as backup EVR System / process owner, including metrics, review/approval, and oversight activities
• Other duties as required by organizational needs