Qa Specialist-Coe

QA Specialist-COE (Center of Excellence)
Industry Pharma/Biotech/Clinical Research
Work Experience 4-5 years
City Dublin
State/Province Dublin
Country Ireland
Job Description
About PSC Biotech
Who are we?
PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350 clients in morethan 23 countries worldwide.
We provide cloud-based software solutions forQuality Management and Regulatory Inspections, pharmaceuticals contractmanufacturing professionals, and metrology services to our clients.
'Take your Careerto a new Level'
PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-minded professionalsoperating in the Pharma/ Biotech Industry.
We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse-cultural work setting.
Employee ValueProposition
Employees are the "heartbeat" of PSC Biotech, we provideunparalleled empowering career development though Learning & Developmentin-house training mentorship through constant guidance to facilitate careerprogression.
We believe in creating high performing teams that can exceed ourclient's expectations with regards to quality of all scalable and business unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met.
Overview:
An exciting opportunity has arisen for a QualityAssurance COE (Center of Excellence) Specialist to join our team in Dublin.
Therole ensures that the QA team objectives are effectively achieved, consistentwith requirements to ensure compliance, safety and reliable supply to ourcustomers, aswell as meeting Health Agency regulations and all other applicablegoverning regulations.
This position will report directly to the QualityAssurance COE Lead
Requirements
Responsibilities:
Support various site functional and cross functional tierstructures.
Completes review and approval for CAPAs, change requests,and investigative protocols and final reports.
Responsible for the quality aspects of material andsupplier management, such as compilation of material qualification pack,supplier audit review, supplier management system upkeep.
Involved in the development and review of documentationand quality records in collaboration with other stakeholders such as QC,MS&T, Engineering and Warehouse throughout the product lifecycle e.g.method validation, facility upgrades, qualification protocols, calibrationrecords.
Review and approve GMP documentation / data for accuracyand completeness.
Working cross functionally to ensure projects milestonesare met in a timely manner.
Collaborates with cross-functional team members in theidentification and implementation of continuous improvement initiatives andaction plans.
General:
A self-starter and results-focused, the successfulcandidate will have strong contemporary knowledge of relevant cGMPs,regulations and current industry trends.
Strong collaboration and cross-functional leadershipskills.
Strong verbal and written communication skills, projectmanagement skills.
Technical &Education:
Bachelor's degree (or higher) in Chemistry, Biology,Microbiology, Engineering or Supply Chain in a relevant discipline.
5 years' experience in Quality Control, Quality Assuranceor Pharmaceutical, Vaccine or Biological Operations, or Technical Operations.
2 years of experience in performing the release functionin a regulated environment
Strong knowledge of qualification and implementation ofSingle Use technologies and raw materials for use in a GMP environment.
Strong contemporary knowledge of relevant cGMPs,regulations and current industry trends.
Knowledge of SAP, KNEAT and Veeva system is an advantage.
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