Manufacturing QA specialist

Outstanding global MNC

Your new company
Outstanding global MNC

Your new role

Provide quality oversight of local Drug Product life cycle and E2E manufacturing/Packaging process.。

. Provide quality oversight of site PUW, PW, Environmental Monitoring (EM) and Clean Utility Monitoring

programs as well as QC lab, warehouse operation.

. Oversee Batch Record Review and Batch Disposition process for all local manufactured/packaging


. Provide QA oversight of Planned Event (CAPA) and Unplanned Event (discrepancies and complaints)

execution to ensure quality and compliance of these activities meet PQS and HA requirements.

. Responsible for escalation of significant quality issues following the criteria as defined in the current

governing documents.

3. Principle Roles & Responsibilities / Accountabilities

What you'll need to succeed

● Experience (may vary depending on site size/scope)

. 5 or more years’ work experience in the pharmaceutical or related industry

. 3 or more years’ experience in a commercially licensed GMP facility

● Knowledge/Skills/Competencies

. Professional knowledge of Quality System and QA principles, practices and standards for the

pharmaceutical industry

. Rich knowledge of cGMP relevant to the pharmaceutical industry

. Knowledge of pharmaceutical, biotechnology or medical device related product operations including

local and international quality regulations.

Project management skills

. Demonstrate good verbal and written communication skills in English

. Focus on value and customer / . Learn for the future /

What you'll get in return

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career. #1233333


Job Type
Life Sciences

Talk to a consultant

Talk to Gioia Wang, the specialist consultant managing this position, located in Shanghai
Unit 1205-1212, HKRI Centre One, HKRI Taikoo Hui, 288 Shimen Road (No.1)

Telephone: 02123229656

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