Associate Quality Specialist (Quality Systems)

Associate Quality Specialist (Quality Systems)

• Industry Pharma/Biotech/Clinical Research
• Work Experience 1-3 years
• City Cork
• 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. Responsible for ensuring that the process for the manufacture of drug product at our Carlow site is in compliance with cGMP and the associated regulatory requirements. Responsible for reviewing and approving GMP documentation to support corporate compliance/regulatory expectations for manufacturing operations. Ensure that objectives are effectively achieved, consistent with the company's requirements to ensure compliance, safety and reliable supply to our customers. This position within the QAdepartment will provide Quality oversight, support and knowledge to activitiesrelating to Quality 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 Associate Quality Specialist is accountablefor the Quality Systems within the site. This role requires the delivery of a robust Quality Management System to supporta 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 company’s Leadershipbehaviours and understand the MPS principles to drive a culture of continuousimprovement building a High-Performance Organisation. The Quality Specialist will participate and comply with the Quality ManagementSystem (QMS) requirements, including ownership. Primary activities/responsibilities:

• Provides to the site knowledge and experiencein Quality Systems.
• Uses knowledge to improve Quality Systems,solve problems, provide continuous improvement, and execute tasks.
• Provides compliance contribution to projectteams and leads small projects.
• Coaches and guides colleagues within the site.
• Understands and applies regulatory /compliance requirements to their role together with remaining current onupcoming regulatory and compliance changes.
• Responds to non-standard requests fromcustomer needs.
• Makes decisions within guidelines and policieswhich impact own priorities and allocation of time to meet deadlines.
• Supports Corporate Quality to ensure actionsrelated to Quality Systems at the site are executed.
• Participation in inspections of Site byDivisional / Regulatory Bodies / third parties together with follow upactions where applicable.
• Participation in and leading internalinspections
• Participate in GMP Walkthroughs.
• Deviation Management & Change Controlapproval.
• Ensures supply of high-quality product throughthe implementation and oversight of the Quality Management System for thesite.
• Champion the highest Quality and Compliancestandards for the site.
• Ensure highest safety standards.
• Additional activities as requested by QA Lead

Requirements

Required:

• Degree or 3rd level qualification (Science,Quality).
• Demonstrated knowledge in more than onepharmaceutical and/or chemical manufacturing operation
• 5 years’ experience in the Pharmaceuticalindustry or a similar operating environment which includes experience in aQuality function
• Quality Assurance SME knowledge, from bothoperational and educational experience, is required
• Knowledge and experience in interpretingcurrent regulatory requirements and providing independent support to thesite
• Demonstrated ability to work independently andfully realize improvement initiatives with a moderate level of guidance
• Demonstrated ability to work and succeedwithin teams as well as leading small project teams.
• Demonstrated ability to drive the completionof tasks.
• Proven track record of providing independentQuality support to the site.
• Advanced PC skills such as Excel, Word,PowerPoint.
• Stakeholder management of multiple decisionmakers, auditors, cross functional teams by demonstrating the ability tomaintain and strengthen trust relationships with people on all levels.
• Proven decision-making capability with fullaccountability and responsibility.
• Energetic with proactive & positiveattitude.

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