1+ months

QA Supervisor

Pfizer
Wuxi
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**Purpose**

Responsible for coordinating QA work in Wuxi Site. To be responsible for in-process inspection and control tests for the whole production process to ensure the whole production process control to be in compliance with plant procedures. To review batch records and in-process control records to ensure the accuracy. To organize and coordinate sampling and testing of packaging materials, and complete timely releasing. To organize and coordinate deviation investigating, participate into Quality system maintaining work, such as PDOCS supplier ' s management, training system, QTS, GMP inspections, complaints and validation. As Compliance Network Member, QA supervisor need ensure effectively tracking all quality and regulatory changes and ensure effective the regulatory changing communication with WRS team. To complete other associated work assigned by QO Manager.

**Responsibility scope**

In-process control:

To organize and coordinate start-up inspection for manufacturing facilities/equipments, in-process inspection according to plant procedure to ensure that production activity compliance with the GMP.

Document review: To organize and coordinate entering and reviewing or other operation of sample information and in-process tests results; Review batch record. Test of Packaging Materials:

To organize and coordinate reviewing of the Artwork of Packaging material and approving of color swatch and bar code. To conduct sampling and testing of Packaging material, coordinating and ensuring timely releasing of packaging material.

Release of semi-finish good and packaging material and issuing of material Code No.: To organize and coordinate reviewing of production in-process document, it is allowed to perform semi-finish good release after entirety training. To coordinate releasing of packaging material. Drafting and revising of Procedure:

To organize and coordinate drafting and revising of procedure, quality specification and test method of packaging material.

Complete related data sorting document managing and filing.

Deviation investigation: To organize and coordinate investigating and handling. Quality system:



+ Document management: Responsible for PDOCS system ( Pfizer global supply document management system) and all documents distribution.

+ Complaint: Responsible for customers complaints and Quality Tracking system of CITI module system management .

+ Supplier management: Maintenance qualified supplier list and documents. Supplier audit and assessment.

+ Training: cooperate with Training Lead to manage the training system and PLS system( Pfizer Global Supply Learning Solution ).

+ Quality tracing: Responsible for QTS ( Quality Tracking system) management and ensure all MIR(Manufacturing Investigation Report)/LIR(Laboratory Investigation Report)/CAPA( C orrective Action/Prevention Action )/CC (Change Control)are completed and compliance with SOP.

+ Inner/outer audit: Dominate internal QA audit and external supplier audit.

+ Validation: Responsible for leading site validation work and validation system management.

+ Changing or Returning: Dominate and coordinate the dealing of products returning.

+ Change control: Dominate assessing and implementing of change control. As Compliance Network Member, QA supervisor need ensure effectively tracking all quality and regulatory changes and ensure effective the regulatory changing communication with WRS team.

+ Market Action: Dominate market action related work, complete organization coordinating of simulating recall, and deal with recalls.



Training: To conduct quality control and quality assurance related training to corresponding persons. Train new QA technicians. Personnel Management/Project Management: Responsible for QA work of designated area in Wuxi Site, and management of QA staffs. Responsible for organizing and coordinating of developing and performing of every QA related project in the plants. QA System managementResponsible for the quality computer systems management at site level. Complete other related work assigned by QO manager.

**Job requirements**

Education Background/ Experience



+ Have a Bachelor's degree or above, related major of pharmacy, pharmaceutical analysis, analytical chemistry or chemistry etc.

+ Have more than 3 years of working experience in pharmaceutical plant.



Special Knowledge



+ Master PQS(Pfizer Quality Standard), GMP and related regulations.



Skills



+ Have good English and computer application ability.

+ To be cooperative and have sense of responsibility.

+ Have capability of communication and training.



**Resource Managed**

Financial indicators

N/A

Non-financial indicators

N/A

S u bordinate number

2



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.



Quality Assurance and Control



\#LI-PFE
Posted: 2021-03-17 Expires: 2021-04-17
Sponsored by:
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QA Supervisor

Pfizer
Wuxi

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