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| Position |
OQA Section Manager |
| Company Info |
An European company in Phar. Industry. |
| Responsibilities |
Key Responsibilities主要岗位职责:
1. Establish systems to comply GMP, International, Corporate and Local standards by continuous improvement.
2. Perform QMS/SOP training to address major compliance gaps and introduce best practices.
Maintain site quality document control, retention system and information security system.
Review and approve all SOPs, and quality documents, drawings which link with throughout production.
Review entire batch records and monitoring system record for product release in order to ensure product quality meet standards.
Conduct batch release for batches with deviation and OOS.
Establish and maintain the quality system for EU market product, communicate with UK QP for any incident/deviation, planned change.
Establish incident/ deviation, customer complaint and Expanded OOS investigation report system to keep effective tracking to process.
Manage and maintain change control procedure and system, contact with external group for level 3 change request.
Maintain annual product review system, organize and prepare annual product review report.
Maintain CAPA system which is raised from incident/deviation, customer complaint, gap analysis and on-line inspection to implement continuous improvement.
Organize and monitor customer complaints to provide timely feedback.
Batch release for normal products
Monitor and summarize quality KPI report.
Establish trend analysis and monitor system which comes from periodic product review, KPI, etc to provide SLT any signature for excursion or improvement opportunity.
Accountability 责任:
¨ primary deliverables of role; it's scope; impact on strategy, policy, business or people relationships
责任范围，对公司战略、政策、业务及人际关系的影响程度
· Provide leadership to build an effective, competent QA section to influence change towards positive quality mindset.
· Provide leadership to enable a secure source of supply of high quality products.
Manage and mitigate significant quality risks in GSKT through risk identification and full use of available risk management process.
Improve Quality and Compliance Culture at GSKT
Deliver greater effectiveness through development and succession planning activities at GSKT
Maintain frequent communication with subordinates to improve team performance.
Ensure a safe workplace environment |
| Requirements |
Specialized Knowledge 专业知识:
¨ breadth & depth across disciplines or functions; expertise in field required
所需知识的宽度（跨学科），所需知识的深度 （特定学科）
University graduate or higher in appropriate field.
Appropriate level of experience( Minimum 5 years experience in pharmaceutical manufacturing )
Broad base of knowledge (Be familiar with GMP, GLP and other relative national regulation; GQP/GQG/FPG/CAP requirements.)
Commercial awareness of business environment
Ability to obtain information objectively
Leadership and influencing abilities
Ability to add value to the business
Understanding of ‘Systems’ and ‘Process’ approaches
Can insist on “Do the right thing”.
Can be fairness and openness in decision making
Hands on with computers for routine work.
Good English oral and writing skills.
Good training skill.
Good project management skill. |
| Update |
2014-09-26 |
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