ME Compliance Staff

ME Compliance Staff
Responsible for ensuring Mechanical Engineering (ME) and EHS-related activities comply with cGMP and applicable regulations. Supports compliance documentation, CAPA implementation, SOP management, and other quality and compliance activities throughout the project.

Accountabilities

• Review and assess ME and EHS activities to ensure compliance with cGMP, applicable regulations, and company requirements.

• Review, develop, and revise ME-EHS SOPs and related documents to ensure they are relevant, up to date, and properly implemented.

• Prepare and maintain reports, documentation, and supporting records required for CAPA implementation and closure.

• Support compliance-related activities and documentation throughout the pharmaceutical facility development project.

• Perform other compliance-related activities or tasks as assigned by the superior or company.

 
Education Requirements
Bachelor's Degree in Pharmacy or related field.

Experience Requirements

• Minimum 2 years of experience in the pharmaceutical industry.

• Good understanding of cGMP requirements and pharmaceutical quality systems.

• Understanding of Good Distribution Practice (GDP) and pharmaceutical facility requirements.

• Good understanding of pharmaceutical manufacturing and facility-related activities.

• Proficient in Microsoft Office.

• Good command of English, both verbal and written.