Qa Downstream Operations Associate Specialist-Shift

QA Downstream Operations Associate Specialist-ShiftIndustry Pharma / Biotech / Clinical ResearchWork Experience 4-5 yearsCity DublinState / Province DublinCountry IrelandJob DescriptionAbout 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 Career to 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 Value Proposition 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 amazing opportunity has arisen for a QA DownstreamOperations Associate Specialist at our site.

RequirementsJob Purpose : The Quality Associate Specialist ensures adherence toGood Manufacturing and Documentation Practices, Quality Manual and local procedures.

TheQuality Specialist spends significant time on the shop floor in a teamenvironment to provide quality coaching and guidance, to enable documentationto be completed right the first time, and to ensure compliance with cGMPs andregulatory requirements.

Role Functions : Provide direct Quality support to production and supportareas.

Provides presence on the shop floor to support complianceand data integrity.

Review and approve GMP documentation / data for accuracyand completeness.

Review and approve executed production documentation suchas electronic batch records and logbooks to ensure accuracy and compliance withcGMPs and company procedures and ensures completion of proper remediation oferrors.

QA support, review and approval of C&Q, Performancequalification (PQ) & Process Validation documents.

Support sustaining activities such as change management,deviations, CAPAs, equipment requalification, periodic review, site maintenance& Calibration Programs.

Provides support to internal audits and regulatoryinspections.

Collaborates with cross-functional team members in theidentification and implementation of continuous improvement initiatives andaction plans.

Experience, Knowledge & Skills : Motivation to be an inspiring member of a high performingteam.

Desire to continuously learn, improve and develop.

Leadership skills coupled with good oral and writtencommunication skills.

Demonstrated interpersonal skills including flexibility,collaboration and inclusion skills and ability to work / upskill / coach a teamenvironment.

Knowledge of cGMPs and of regulatory requirements as theyapply to the pharmaceutical field.

Technical writing skills.

Lean Six-sigma and problem solving tools.

Qualifications & Education : Bachelor degree, in a scientific or engineering field.

3 years of relevant post-degree experience in a GMPenvironment : manufacturing, laboratory, quality, operations, technical, orregulatory function.

Shift Pattern : Shift will be 4 days on, 4 days offwith 12 Hour Shifts

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