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    Associate Quality Specialist - Ireland - PSC Biotech Corporation

    PSC Biotech Corporation
    PSC Biotech Corporation Ireland

    5 days ago

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    Description

    Associate Quality Specialist (Quality Systems)

    Cork city, Ireland | Posted on 01/26/2024

    • Industry Pharma/Biotech/Clinical Research
    • Work Experience 4-5 years
    • City Cork city
    • State/Province Cork
    • 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.

    This position within the QA department willprovide Quality oversight, support and knowledge to activities relating toQuality Systems across the site and in meeting the priorities of:Compliance, Supply, Strategy and Profit Plan.

    The team working style is one of collaboration, coaching and facilitation toensure the success of the site. The Quality Specialist is accountable for theQuality Systems within the site.

    This role requires the delivery of a robust Quality Management System tosupport a flexible, collaborative, multi-skilled teamwork environment. The Quality Specialist will have proven capability in development of QualitySystems as an active member, across cross functional teams, to deliver processimprovement. The Quality Specialist will model the Leadership behavioursand understand the MPS principles to drive a culture of continuous improvementbuilding a High-Performance Organisation. The Quality Specialist will participate and comply with the QualityManagement System (QMS) requirements, including ownership as required. Primary activities/responsibilities:
    • Required to be proficient in Quality approval and oversight forCommissioning and Qualification activities (IQ/OQ/PQ)
    • Provides to the site expertise in Quality Systems and/orOperational Quality, including the following i.e. QualityNotifications/Investigations/ Change Management; environment monitoringprograms; sterility assurance/low bioburden manufacturing; etc.
    • Uses knowledge to improve Quality Systems and/or OperationalQuality; solve complex problems, provide continuous improvement andexecute tasks.
    • Acts as a resource to colleagues with less experience in QualitySystems and/or Operational Quality
    • Understands and applies regulatory / compliance requirements totheir role together with remaining current on upcoming regulatory andcompliance changes
    • Interprets customer needs, assesses requirements and identifiessolutions to non-standard requests.
    • Makes decisions within guidelines and policies which impact ProductQuality, Projects and Quality Systems.
    • Uses knowledge to improve Quality Systems, solve problems, providecontinuous improvement, and execute tasks.
    • Provides compliance contribution to project teams and leads smallprojects.
    • Coaches and guides colleagues within the site.
    • Responds to non-standard requests from customer needs.
    • Makes decisions within guidelines and policies which impact ownpriorities and allocation of time to meet deadlines.
    • Supports Corporate Quality to ensure actions related to QualitySystems at the site are executed.
    • Participation in inspections of Site by Divisional / RegulatoryBodies / third parties together with follow up actions where applicable.
    • Participate in GMP Walkthroughs.
    • Deviation Management & Change Control approval.
    • Ensures supply of high-quality product through the implementationand oversight of the Quality Management System for the site.
    • Champion the highest Quality and Compliance standards for the site.
    • Ensure highest safety standards.
    • Additional activities as requested by QA Lead

    Requirements

    • Degree or 3rd level qualification (Science, Quality).
    • Demonstrated knowledge in more than one pharmaceutical and/orchemical manufacturing operation.
    • 5 years' experience in the pharmaceutical industry or a similaroperating environment which includes experience in a Quality function
    • Quality Assurance SME knowledge, from both operational andeducational experience, is required.
    • Knowledge and experience in interpreting current regulatoryrequirements and providing independent support to the site
    • Demonstrated ability to work independently and fully realizeimprovement initiatives with a moderate level of guidance.
    • Demonstrated ability to work and succeed within teams as well asleading small project teams.
    • Demonstrated ability to drive the completion of tasks.
    • Proven track record of providing independent Quality support to thesite.
    • Advanced PC skills such as Excel, Word, PowerPoint.
    • Stakeholder management of multiple decision makers, auditors, crossfunctional teams by demonstrating the ability to maintain and strengthentrust relationships with people on all levels.
    • Proven decision-making capability with full accountability andresponsibility.
    • Energetic with proactive & positive attitude.
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