Major Accountabilities

Operational

• Provide shop-floor QA support and oversight of production and testing activities, ensures compliance with cGxP, ISO9001, incl. data integrity and eCompliance
• Batch document review, support product release
• Support deviation and compliant investigations within MU, QC, Engineering and warehouse and other relevant areas.
• Performs routine documentation activities
• Supports change control activities
• Review and approval of production and QC documents and records
• MBR review
• IPC oversight
• Support OpEx improvement projects
• Support internal and external audit or inspection activities

HSE

• Comply with all HSE guidelines
• Detect and report potential accident, risks and propose solutions
• Participate in HSE risk assessments
• Preparation and participation to internal HSE audits
• Responsible for participating in initial training and retraining

Key Performance Indicators 

• Executes product-related activities in timely manner according to cGxP and in compliance with registration
• Demonstrated positive trends in key quality management process measures. Successfully support continuous improvement projects

Experience:

• More than 3 years of experience in pharmaceutical quality control, quality assurance or production
• Operations Management and Execution; Functional Breadth; Collaborating across boundaries; Applied Practice

Education & Qualification:

• University degree with a scientific / technological background (e.g. Chemistry, Pharmacy, Biology, Biochemistry, or equivalent)
• Qualified Person (depending on local requirements)

Languages:

Good (oral and written) in English; fluent in local language (oral and written)