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QA Specialist (Manufacturing)

Pfizer


Location:
Tuas South Ave 6
Date:
01/30/2018
2018-01-302018-03-02
Pfizer
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Job Details

**POSITION SUMMARY:**







We are looking for individual who is interested to have a career switch and pursue an exciting role in a dynamic environment in Pfizer Active Pharmaceutical Ingredient (API) manufacturing Plant. The incumbent is preferably to have experience in production batch record review, investigation of non-conformance, root cause analysis, change control management, familiar with ERP system to manage batch status in the manufacturing, packaging and labeling industries and would like to experience similar scope of work in the pharmaceutical industry. The incumbent should also be able to work with internal and external stakeholders to ensure on time batch release and be driven to meet timeline of the assigned task/ project. Individual with a good understand of ISO 9001, FSSC, HACCP process will be an added advantage.







Training will be provided to the incumbent on current code of Good Manufacturing Practice (cGMP) and internal Pfizer Quality Standard (PQS) to ensure smooth career transition to the Pharmaceutical industry.







**POSITION RESPONSIBILITIES** :



Responsibilities:







+ Responsible to review and approve master batch records and subsequent batch records associated with the manufacturing, packaging and labeling of intermediates and active pharmaceutical ingredients (API) to ensure batches produced are in compliance with Pfizer quality standards and regulatory registered specifications.



+ Disposition the intermediates and active pharmaceutical ingredients (API).







+ Work with supply chain and drug product sites to ensure timely delivery of quality products



+ Participate in change control process with cross functional subject matter expert and ensure impact assessment is adequate and thorough.



+ Review and approve cleaning records and procedures



+ Improve quality assurance systems, as necessary.



+ Review and approve deviations according to the site procedures. This includes participating with cross functional team in root cause analysis, performing the impact assessment with the subject matter experts for quality, validation and/ or regulatory impact, ensuring the adequacy of the associated corrective actions and/or preventive actions, reviewing and approving the investigation reports. Ensure issues are escalated duly according to the Pfizer Quality Standards (PQS).



+ Handle product complaints and ensure complaints are investigated thoroughly with CAPAs effective to prevent recurrence.



+ Maintain current quality tracking systems and the quality metrics to proactively identify trends and atypical observations.



+ Coordinate with cross-functional team to prepare Annual Product Record Reviews, discuss trends & atypical observations and recommend improvement actions.



+ Conduct internal audits to ensure the internal controls are effective. Conduct external audits to ensure adequate oversight to suppliers/ service providers and collaborate with supplier to reduce starting material quality issues.



+ Maintain inspection readiness and support inspections from regulatory agencies and customers. Actively participate in GMP walk downs to ensure site operation and facility maintained in inspection ready state.



+ Support the maintenance of validated stated of GMP systems and processes.



+ Participate/ lead continuous improvement project to improve work processes and quality system.







Job Relate Requirements :







+ Successful track record of continuous improvement, development, and/or implementation of best practices in quality operations or manufacturing.



+ Previous Quality Assurance and GMP Compliance experience.



+ Demonstrated ability to interact effectively with management and cross functional department stakeholders



+ Ability to interact effectively in teams and facilitate team discussions.







Accountabilities:







+ Ensure compliance activities are carried out as per approved procedures and policies.



+ Conduct internal audit to ensure compliance to Pfizer Quality Systems (PQS).



+ Reviewing and approving change controls and deviation investigations.



+ Reviewing and approving GMP documents.



+ Manage GMP compliance systems e.g. QTS, PDOCS







**ORGANIZATIONAL RELATIONSHIPS:**



The incumbent will interact with all site departments for QA related operations and activities i.e. Manufacturing Operations, Process Teams, Quality Control, Warehouse and Tank Farm teams and Engineering functions. In the event of quality related issues, this position will interact with quality or regulatory representatives from drug product sites or Global Chemistry Manufacturing & Compliance (GCMC) teams.







**EDUCATION:**



A Bachelor Degree in Science / Chemical Engineering or equivalent with relevant Quality Assurance experience. Familiar with the self-directed team concept; manufacturing operations applications; six sigma and lean principles and process improvement tools.







**EXPERIENCE :**



Minimum 1 to 3 years' experience in Quality Assurance/Compliance roles and familiar with ISO 9001, FSSC, HACCP process etc would be an advantage. Fresh Graduates who can demonstrate through their project work that they have an understanding of Quality Assurance principles; for example ISO 9001 systems and processes are encouraged to apply.



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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