Budget: #100,000-1200,00

Responsibilities

• Coordinate and perform batch record disposition of development, finished products, and raw materials.
• Review and approve manufacturing and QC related documents for batch record disposition.
• Provide risk-assessment tracking and other established mechanisms for risk assessment.
• Initiate, Review, and approve deviations, change controls, facility Work Orders, and any other site/product-related documents ensuring adequate levels of documentation are adequate and compliant to existing procedures.
• Drive continuous improvement and enhancement efforts to the Disposition process to ensure an efficient yet Compliant process is maintained.
• Develop reports and analyses to expose potential risks and gaps that need corrective action or preventative action.
• Compose and disseminate standardized internal communications to pharmaceutical personnel on important compliance developments, company policies, and procedures.
• Support quality manual implementation teams in area of technical expertise as required.
• Support regulatory agency inspections, by way of auditing, training, and preparation, and tracking commitments.
• Write, review, and approve Policies, Standard Operating Procedures (SOPs) and associated processes/guidelines.

Requirements

• Bachelor’s degree in degree in pharmacy, chemistry, relevant field.
• A minimum of 2 years’ experience as a compliance officer, compliance manager, or similar position.
• Familiarity with industry practices and professional standards
• Exposure and hands-on experience in handling different roles at different manufacturing disciplines (e.g., Production, Quality, Engineering, EHS) is a plus.
• Outstanding communication and interpersonal abilities.