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Supply Chain Quality Operations Specialist

Pfizer


Location:
Tuas South Ave 6
Date:
02/06/2018
2018-02-062018-03-09
Pfizer
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Job Details

The Supply Chain Quality Operations Specialist is responsible for assuring full compliance of Hospira/Pfizer products to Pfizer quality standards and regulatory requirements. Responsible for the implementation, execution and monitoring of redressing activities at the ALC. Provides Quality oversight at contracted Logistic Service Providers providing secondary repackaging. Proactively partners with Affiliate Quality Operations, Regulatory, ALC Operations team and the LSP to ensure that all redressing/repackaging operations are in compliance with cGMP's, Regulatory standards and Pfizer Policy.







Develop, review GMP/GDP related SOPs related to redressing and ALC operations



Prepare, review and maintain material and product specifications, redressing instructions and other GMP related documentation for redressed products



Perform batch release for redressed products



Support and ensure compliance of the ALC Quality System



Coordinates GMP related activities with AQOs and regulatory team to ensure compliance to market requirements



Assure the investigations, corrective/preventive actions and commitments are in compliance with Pfizer standards



Responsible for leading or assisting in root cause investigation in the event of a non-conformance



Present formal notifications of significant issues to senior management



Support conduct of third party due diligence and vendor assurance audits



Execute quality holds, product notifications and product recalls as directed



Manage quality processes for any product returns and material for destruction



Participate in internal and external audits



Resolve and conclude deviations and excursions within agreed leadtime



Ensure Logistics Services Providers SOPs are 'substantially equivalent' to the requirements within applicable Pfizer policies



Assist GSCPM and QO colleagues in establishing processes that safeguard quality, compliance as well as continuity of supply



Facilitate quality culture by demonstrating compliance and initiating Zero Defects



Perform other jobs which may be assigned







Bachelor Degree in Pharmacy, Chemistry, Biology, Microbiology, Biochemistry, Engineering or similar related disciplines



Minimum 5 years prior experience is required in position of increasing responsibility within Quality Assurance or other relevant quality functions within the pharmaceutical industry



Experience in logistics and supply operation is highly desirable



Strong communication and interpersonal skills to guide and lead cross-functional project groups



Adaptable to work priorities in response to complex and/or rapidly changing environments



Able to deliver results with limited resources



Ability to define, evaluate, recommend and implement continuous improvement opportunities in the regulatory compliance areas



SAP knowledge is preferredThe Supply Chain Quality Operations Specialist is responsible for assuring full compliance of Hospira/Pfizer products to Pfizer quality standards and regulatory requirements. Responsible for the implementation, execution & monitoring of redressing activities at the ALC. Provides Quality oversight at contracted Logistic Service Providers providing secondary repackaging. Proactively partners with Affiliate Quality Operations, Regulatory, ALC Operations team and the LSP to ensure that all redressing/repackaging operations are in compliance with cGMP's, Regulatory standards and Pfizer Policy.







The Supply Chain Quality Operations Specialist will provide other quality support as may be required.







Bachelors Degree in Pharmacy, Chemistry or Allied Sciences. Minimum 5 years experience in Pharmaceutical quality operations, repackaging and manufacturing. Strong verbal and written communication skills



Flexi Work - Tuas (Singapore)



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