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QA Operations Specialist

2 months ago

Dublin, Dublin City, Ireland PSC Biotech Corporation Full time

County Meath, Ireland | Posted on 06/10/2024

  • Industry Pharma/Biotech/Clinical Research
  • Work Experience 4-5 years
  • City County 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 point 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 purpose:

· This role will be part of ourQA Operations Self Directed Work Team (SDWT) in our state-of-the-art single usemulti-product biotech facility, County Meath, Ireland.

· The QA Operations Specialistrole involves supporting the operational activities, technical transfers,regulatory approvals and commercial operations at the single use multi-productbiotech facility.

· The QA Operations Specialistwill work across the site self-directed work teams and hub teams to identifyand resolve issues to allow the site to deliver on our commit culture thatsupport Quality, EHS, Learning and Continuous improvement.

· The QA Operations Specialistwill be responsible for supporting the Operations team, ensuring compliancewith cGMP and corporate regulations.

Requirements

Key accountabilities:

· Provide QA oversight to thequalification/validation, technical transfers, regulatory approvals andcommercial operations at the facility.

· Review/Approval ofvalidation/Qualification/verification protocols and reports associated with newproduct or material entry.

· Helps maintain site practicesand procedures related to facility start-up, instrument qualification, usage,technology transfer execution, and commercial manufacturing.

· Responsibility for adhering todomestic and international GMP regulations, cGMP's, company policies,leadership behaviours, and performance and budget management.

· Responsible for supportingexecution of an effective Quality system and accountable for quality oversightof quality management systems (CAPAs, Change Controls, Deviations BatchDocumentation Review).

· Reviews and approves batchrecords, discrepancy reporting, investigations and CAPAs associated with allareas of Manufacturing operations.

· Liaises with internal partners(e.g. Manufacturing Operations, Process development technical services (PD-TS),Engineering functions etc) in support of daily operations.

· Coordinate with peer Qualitygroups to ensure on-time disposition of commercial Drug Substance.

· Ensures clear communication onissues and timely escalation as applicable.

· Provide support and expertisefor the preparation of regulatory submissions, inspection readiness activities,during health authority inspections including interaction with inspectors,responses to inspection observations, and monitoring of follow up actions.

· Champion site metrics to ensuretargets are achieved, met and counter measures in place when applicable.

· Representing Quality onmultidisciplinary teams.

· Executing company policies.

· Ensures new/revised qualitysystem requirements are deployed to the Site.

· Ability to work on his/her owninitiative in addition to working as part of a team and must be open to 24/7shift work. Must be able to work across a team matrix to meet acceleratedtimelines.

Education and experience requirements:

· Degree or post-graduatequalification in Science, Pharmacy or equivalent.

· 4+ years' experience in QA.

· Demonstrated knowledge ofQuality Management System tools, continuous improvement methodologies &in-depth understanding of site level products & related processes.

· Demonstrated expertise toeffectively communicate within all levels of the organization around conceptsof design controls, design verification and validation activities; production& process controls; Corrective & Preventive Action (CAPA), complaints& risk management; & product quality improvement using tools such assix sigma, DFR, etc.

· Demonstrated collaboration,negotiation & conflict resolution skills.

· Excellent communication skills(written and oral).

· Required to work on his/her owninitiative in addition to working as part of a team and must be open to shiftwork (including 24/7 shift pattern). Must be able to work across a team matrix tomeet accelerated timelines.

· Demonstrated understanding ofcontinuous quality / process improvement tools (As defined by the site, e.g.DMAIC, Lean QA, 5S etc).

· Experience in performinginternal audits and participating in external audits.

· Exceptional analytical, problemsolving & root-cause analysis skills.

· Ability to multi-task andhandle tasks with competing priorities effectively.

· Strong technical aptitude to read & comprehend technical documentation & executeprocedures), global regulatory experience & demonstrated experienceinterfacing with regulators.

· Experience with working in amultinational organisation.

· Strong operations supportbackground ensuring value added and effective quality oversight

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