Coordinate and performs 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 with existing procedures.
Ensure the Disposition process meets industry expectations and requirements.
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 areas of technical expertise as required.
Support regulatory agency inspections, by way of auditing, training, preparation, and tracking commitments.
Support maintenance of central file for correctives and inspection history.
Write, review, and approve Policies, Standard Operating Procedures (SOPs), and associated processes/guidelines.
Participate in the internal audit program.
REQUIREMENTS
Bachelor’s degree in degree in pharmacy, chemistry, and relevant field.
A minimum of 2 years experience as a compliance officer, compliance manager, or similar position.
Strong knowledge of industry processes and regulations.
Familiarity with industry practices and professional standards
Exposure and hands-on experience in handling different roles in different manufacturing disciplines (e.g., Production, Quality, Engineering, EHS) is a plus.
Outstanding communication and interpersonal abilities.
An analytical mindset with excellent organizational skills.