1+ months

/Product Release Engineer

Oviedo, Principado de Asturias 33012
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+ cGMPPQSMaintain and optimize production batch record review procedure, and is 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.

+ cGMPPQSResponsible for surveillance of production process e.g. compounding, drug substance, and effectively handle on-line problem in a timely manner when it presents, to ensure product quality and compliant with cGMP and PQS requirement.

+ CAPA//QTSLead DS area deviation/complaint investigation and perform impact assessment, participate in CAPA initiation and effectiveness check; Trends analysis for deviation/quality complaint and continuous improvement etc.; Approve event report in QTS system;

+ Develop annual product quality review plan; perform product quality review as planned; trends analysis and take necessary CAPAs etc.

+ /PQSManagement of DS area 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.

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

+ GMPManagement of material quality control system, to ensure only materials that meet cGMP requirements and quality specification are release for production. It includes but not limited to: manage material receiving, storage, sampling, release, status control, material release, unqualified material control, returned goods manage; review material quality specification.

+ Participate in company audit readiness plan, It includes but not limited to: act as auditor to perform internal audit; act as auditee to support internal/external audit; support plant performed supplier audit.

+ Create Cooperative, Open and Compliance working atmosphere; act as quality representative to participate in the communication meeting of operation department and share the quality performance, acknowledge of assistance need from quality and provide relevant support, keep effective communication with OPS department.


Execute any other related work assigned by company.

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
Posted: 2020-10-13 Expires: 2020-12-13
Sponsored by:
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/Product Release Engineer

Oviedo, Principado de Asturias 33012

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