深圳招聘

Position Details:
Position Title: Senior Officer / Officer, Quality Validation (Process Automation Qualification)
Division: Quality Unit
Reports to: Manager, Quality Validation
Location: Shanghai

Primary Purpose of Job (Job Summary)
Ensure qualification and validation activities, especially process automation qualification in Technical compliance with relevant company policy, headquarter guideline and regulatory requirements.

Principle Roles & Responsibilities / Accountabilities
Oversight Process Automation Qualification activities in Technical Division to ensure the compliance of procedures, guidelines and regulations
By reviewing relevant qualification/technical documents, test data, operation procedures and other related documents to ensure PAQ implementation meet the HQ and regulation's requirement.
By attending project teams if appropriate to monitor project implementation's compliance with the HQ and regulation's requirement in project life cycle.
? Review qualification and validation documents
By compliance review of qualification and validation plans and reports, and other related documents for document completeness, GMP compliance and data acceptability, majoring for the equipment/facility with automation control systems and computerized systems.
? Support the running of Laboratory Information Management System
By supporting CSV staff for the managing, updating documentation system, cross-team coordination with other group/department/Informatics,
By giving training and coaching of technical knowledge and skills to users, solving problem to make the system always keeping the required level.
? Support activities
By providing support to other quality validation activities as required by superior

Qualification and Experience
Education/Qualifications
Bachelor of Engineering Degree or above, majoring in Electric Automation, Computer Science/Technology, Mechanical Engineering, or equivalent major.
Job Required Competencies
Professional knowledge of qualification, validation and pharma production, with the experience of process automation system commission or qualification or maintenance
The experience of computerized system commission or qualification will be a plus.
Knowledge of China/EU/FDA GMP requirements
Language skills - English & Chinese

DB Talent is a European based recruitment company. Our Shanghai office opened in the 2001, and we have continually provided excellent professional service to our clients and candidates.