Quality Control Specialist

3 weeks ago

Ireland PSC Biotech Full time
  • Industry Pharma/Biotech/Clinical Research
  • Work Experience 4-5 years
  • City Meath
  • State/Province Meath
  • Country Ireland
Job Description

About PSC Biotech

Who we are?

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling points which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition

Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Job Title: Quality Control Specialis t

· The purpose of this role is towork within and support the Global Development Quality Assurance teamat client cite.

· This role will primarily provide support for ChangeControl, Deviation Management and Supplier Quality Management.

· It will also support interface of SAP with IPIProduct structure and MES BOMs and recipes.Other activities to support Quality Systems and QA Operations will berequired as per start up schedule.

· The QASystems and Compliance Team with work closely with theOperations, Engineering, Validation, Supply Chain and AR&D Functions toensure compliance to Global and Regulatory Quality Management Systemrequirements as they pertain to the client Quality Manual, Change Control,Deviation Management, Supplier Quality Management, Quality Risk Management,Audit Management and associated electronic systems.

Requirements

Therole is required to:

  • Participate daily on cross-functional teams tocollaboratively actively to address compliance issues and achieve projectmilestones.
  • Participate in and lead investigation ofdeviations, risk assessments and changes, ensuring appropriate actions areimplemented timely.
  • Provide QA review and approval of ChangeControls, Deviations/CAPAs, SOPS and related documentation for complianceto GMP and site requirements at the facility.
  • Provide QA oversight to GMP readiness,technical transfers, regulatory approvals and clinical operations at thefacility.
  • Assist in the development of trainingcurricula and records for QA and providing SME training on QualityAssurance SOPs as required.
  • Assist in the creation and maintenance of QA SOPs,metrics and reports in line with site requirements.
  • Support an environment of continuousimprovement by identifying and implementing efficiencies and qualityimprovements.
  • Work collaboratively to foster strongrelationships with management and colleagues and to drive a safe andcompliant culture.
  • Ensure the escalation of compliance risks tomanagement in a timely manner.

What skills you will need:

In order to excel in this role, you will more than likely have:

  • Bachelor’s degree, or higher (Science/Quality/Technical).
  • 4-5 years’ experience,ideally in QualityAssurance, Quality Control or Technical Operations within the Biologicaland/or pharmaceutical industry.
  • Previous experience in QRM, SQM, Deviationsand Change Control, participating in investigations and problem solving.
  • Strong attention to detail and precision inpreparing and reviewing GMP documentation.
  • Strong written and verbal communicationskills.
  • Ability to think logically and be proactiveunder the variable schedules of a startup site.
  • Ability to work as part of a team and on owninitiative in a constructive manner.
  • Strong attention to detail and precision inpreparing and reviewing GMP documentation.
  • Previous experience in quality managementsystems such as Veeva, SAP, PAS-X, Delta V, Trackwise etc.
  • Knowledge of industrial regulations includingthose of FDA, HPRA, EMEA and other authorities related to Biologics and/orPharmaceuticals.
  • Experience in direct interactions withregulatory agencies during site inspection.
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