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.
Interested and qualified candidates should forward their CV to: recruitment@willerssolutions.com using the position as subject of email.
Apply via :
recruitment@willerssolutions.com