1+ months

QA analyst/ QA /Secondment

Pfizer
Wuxi
1.

/ GMP

2.

3.

Artwork

4.

5.





6.

7.

PDOCS

PCOM



PLS

QTS CAPA SOP









8. QA

9.QA

10.



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 and all documents distribution.

+ Complaint: Responsible for customers complaints and PCOM 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.

+ Quality tracing: Responsible for QTS management and ensure all MIR/LIR/CAPA/CC 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.



Training: To conduct quality control and quality assurance related training to corresponding persons. Train new QA technicians. QA System managementResponsible for the quality computer systems management at site level. Complete other related work assigned by QO manager.

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

Categories

Posted: 2020-03-16 Expires: 2020-06-17

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QA analyst/ QA /Secondment

Pfizer
Wuxi

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