Quality Manager-Q&C-Shanghai-00000KJV
Description
1. Principal Duties and Responsibilities (General Summary ，essential functions and authorities, etc.)
v Quality management in distribution center of Shanghai
Ø As quality manager, responsible for leading or key team member for quality project in SH-NDC, such as audit of internal, external and J&J ERC, SH-DC extension and Cold Chain in storage and transportation process.
Ø Be responsible for lead and manage routine quality management in operation process, such as NC, CAPA Case and process improvement in SH-DC
Ø Be responsibility for lead and manage QA Engineer/Technician/3rd PL Inspector in SH-DC
v Chinese label quality control for incoming goods
Ø Be responsible for lead and review that QA Engineer/Technician complete the change control process for Chinese label according to requirements, and establish the process/protocol to meet company’s requirements if necessary;
Ø Be responsible for review and approve the first article inspection for Chinese label and release the product in ERP system in time, and monitor the routine Chinese label release if need;
Ø Be responsible for review the change control process for Chinese label from Label-View system as BCP, and correct the defect Chinese label on site. At the same time to update the Label-View Chinese label standard. If necessary, correct the impact inventory and impact goods which in distributors.
Ø Be responsible for review the Chinese label standards weekly which initiated by QA Engineer/ Technician to be sure all the process are under control;
v Chinese IFU quality control for incoming goods
Ø Be responsible for finish the change control process for Chinese IFU according to requirements, and establish the process/protocol to meet company’s requirements if necessary;
Ø Be responsible for monitor the Chinese IFUs insert process locally, and work with related department for Chinese IFU management.
v Incoming goods inspection
Ø Be responsible for review and approve the incoming goods inspection report which is defected by QA Engineer/ Technician;
Ø Be responsible for review the complaint case which report in LOG and be sure the information is correct; Be sure all the complaint report to CHU in 24 hours and record the all files for tracking if need;
Ø Be responsible for review and approve the incoming goods receiving reports which done by QA Engineer/Technician and be sure all the information in goods are match with the licenses, reminder quality engineer for filing all the reports everyday;
v Return goods inspection
Ø Be responsible for review and approve the return goods inspection reports which done by QA Engineer/Technician; and provide quality training and support if necessary;
Ø To communicate with related departments when handle the return case, and provide the resolve protocols for franchise and distributors if necessary;
v Routine monitor in warehouse
Ø Be responsible for review and evaluate the temperature records weekly, be sure all the products are under storage condition;
Ø Be responsible for review the insect pest control records monthly, if have issue, inform Manager in time;
Ø Be responsible for monitor the incoming goods storage and deliver environment, if have issue, inform Manager in time;
v Document management, NC case and CAPA handling
Ø Establish the SOP and GOP for incoming goods quality;
Ø Handling the NC case until close according to current GOP/SOP;
Ø Handling the CAPA until close according to current GOP/SOP;
v Arrange and Fulfill project assigned as a project owner.
v Fulfill other tasks assigned.
v Comply with EHS & ISO14001.
Qualifications
Basic Requirement, including Education and/or Knowledge and/or Training and/or key Relevant Experience required.
v Bachelor degree or above on chemical, pharmaceutical or related subjects.
v Above 10 years experience in quality compliance management or related areas in medical device or pharmaceutical industries.
v Good communication, cooperation and organization skills.As
v English fluent in reading, writing, oral, listening.
v Familiar with routine operations of computer and software.
Skill Sets and/or Training and/or Certification for the Special Position
Pharm. License
Quality Engineer
Primary Location:Asia Pacific-China-Shanghai-Shanghai
Organization: Johnson & Johnson Medical Shanghai Ltd. (7055)
Job Function: Quality Assurance
Description
1. Principal Duties and Responsibilities (General Summary ，essential functions and authorities, etc.)
v Quality management in distribution center of Shanghai
Ø As quality manager, responsible for leading or key team member for quality project in SH-NDC, such as audit of internal, external and J&J ERC, SH-DC extension and Cold Chain in storage and transportation process.
Ø Be responsible for lead and manage routine quality management in operation process, such as NC, CAPA Case and process improvement in SH-DC
Ø Be responsibility for lead and manage QA Engineer/Technician/3rd PL Inspector in SH-DC
v Chinese label quality control for incoming goods
Ø Be responsible for lead and review that QA Engineer/Technician complete the change control process for Chinese label according to requirements, and establish the process/protocol to meet company’s requirements if necessary;
Ø Be responsible for review and approve the first article inspection for Chinese label and release the product in ERP system in time, and monitor the routine Chinese label release if need;
Ø Be responsible for review the change control process for Chinese label from Label-View system as BCP, and correct the defect Chinese label on site. At the same time to update the Label-View Chinese label standard. If necessary, correct the impact inventory and impact goods which in distributors.
Ø Be responsible for review the Chinese label standards weekly which initiated by QA Engineer/ Technician to be sure all the process are under control;
v Chinese IFU quality control for incoming goods
Ø Be responsible for finish the change control process for Chinese IFU according to requirements, and establish the process/protocol to meet company’s requirements if necessary;
Ø Be responsible for monitor the Chinese IFUs insert process locally, and work with related department for Chinese IFU management.
v Incoming goods inspection
Ø Be responsible for review and approve the incoming goods inspection report which is defected by QA Engineer/ Technician;
Ø Be responsible for review the complaint case which report in LOG and be sure the information is correct; Be sure all the complaint report to CHU in 24 hours and record the all files for tracking if need;
Ø Be responsible for review and approve the incoming goods receiving reports which done by QA Engineer/Technician and be sure all the information in goods are match with the licenses, reminder quality engineer for filing all the reports everyday;
v Return goods inspection
Ø Be responsible for review and approve the return goods inspection reports which done by QA Engineer/Technician; and provide quality training and support if necessary;
Ø To communicate with related departments when handle the return case, and provide the resolve protocols for franchise and distributors if necessary;
v Routine monitor in warehouse
Ø Be responsible for review and evaluate the temperature records weekly, be sure all the products are under storage condition;
Ø Be responsible for review the insect pest control records monthly, if have issue, inform Manager in time;
Ø Be responsible for monitor the incoming goods storage and deliver environment, if have issue, inform Manager in time;
v Document management, NC case and CAPA handling
Ø Establish the SOP and GOP for incoming goods quality;
Ø Handling the NC case until close according to current GOP/SOP;
Ø Handling the CAPA until close according to current GOP/SOP;
v Arrange and Fulfill project assigned as a project owner.
v Fulfill other tasks assigned.
v Comply with EHS & ISO14001.
Qualifications
Basic Requirement, including Education and/or Knowledge and/or Training and/or key Relevant Experience required.
v Bachelor degree or above on chemical, pharmaceutical or related subjects.
v Above 10 years experience in quality compliance management or related areas in medical device or pharmaceutical industries.
v Good communication, cooperation and organization skills.As
v English fluent in reading, writing, oral, listening.
v Familiar with routine operations of computer and software.
Skill Sets and/or Training and/or Certification for the Special Position
Pharm. License
Quality Engineer
Primary Location:Asia Pacific-China-Shanghai-Shanghai
Organization: Johnson & Johnson Medical Shanghai Ltd. (7055)
Job Function: Quality Assurance