Compliance Officer
4 weeks ago
Budget: #100, ,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.
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