1+ months

/Sr. Product Release Specialist

Pfizer
Plant City, FL 33563
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cGMP

Execute monitor of process and product quality related activities, and released of controlled material under guidance from Product Release Manager, to ensure all parts of end to end process of Product production are executed with compliant of cGMP and Pfizer Quality Standard (PQS) and Specifications, by establishing and execution of oversight, quality control and quality disposition system for materials, production process and Product.



cGMPPQS

Responsible for batch record and support document review, to ensure production master batch sheet and batch record is consistent with product process description, registered process, and compliant with cGMP and PQS requirement.



Responsible for timely identify the online problem, give immediately disposition suggestion, ensure the issue product under control on-line problem in a timely manner when it presents, to ensure product quality and compliant with cGMP and PQS requirement.

GMP

Responsible for material release, establish and administer material complaints management procedure, ensure materials continually meet cGMP requirements and quality specification are release for production. It includes but not limited to: Raw material and excipient and other controlled material release; material quality issue handling; establish material performance database and material complaint system; Follow up on supplier investigation progress; review supplier investigation report and CAPA

CAPA

Participate in site deviation/complaint investigation and perform impact assessment, participate in CAPA initiation and effectiveness check;



Assistant of annual product quality review; perform annually review on material related section and identify improved chance.

PQS

Participate in equipment/process qualification/validation, ensure validate activities compliant with cGMP and PQS requirement. It includes but not limited to: Review qualification/validation protocol and report, participate in validation process and review deviation during validationfollow up on the validation output to ensure the relevant activities carry into execution.

/WI

Review process/machine related WI, it includes but not limited to: machine operation, process description, sanitization, material handling in operation area etc.



Establish material and product sampling procedure, responsible for routine management of sampling room and retention room, it includes but not limited to: material and product sampling procedure, sampling methods, sampling tools management, and retention sample management.

;

Responsible to support quality audit readinesse.g. supporting document collective and review;



Execute any other related work assigned by company.cGMP

Execute monitor of process and product quality related activities, and released of controlled material under guidance from Product Release Manager, to ensure all parts of end to end process of Product production are executed with compliant of cGMP and Pfizer Quality Standard (PQS) and Specifications, by establishing and execution of oversight, quality control and quality disposition system for materials, production process and Product.



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Establish and maintain material spec based on technical transfer document, technical assessment and phamacapia.



+ GMPResponsible for material release, establish and administer material complaints management procedure, ensure materials continually meet cGMP requirements and quality specification are release for production. It includes but not limited to: Raw material and excipient and other controlled material release; material quality issue handling; establish material performance database and material complaint system; Follow up on supplier investigation progress; review supplier investigation report and CAPA

+ CAPAParticipate in site material related deviation/complaint investigation and perform impact assessment, participate in CAPA initiation and effectiveness check;

+ LIRMIR;Review laboratory related investigation;

+ ;Role as material sampling back up person, responsible for the incoming material sampling, and deliver to testing department/location;

+ Assistant of annual product quality review; perform annually review on material related section and identify improved chance.

+ Establish material and product sampling procedure, responsible for routine management of sampling room and retention room, it includes but not limited to: material and product sampling procedure, sampling methods, sampling tools management, and retention sample management.

+ ;Responsible to support quality audit readinesse.g. supporting document collective and review;

+ Execute any other related work assigned by company.



C:Plant Clock Standard - (China)

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Posted: 2019-09-04 Expires: 2020-01-04

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/Sr. Product Release Specialist

Pfizer
Plant City, FL 33563

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