Industry Pharma/Biotech/Clinical Research Work Experience 4-5 years City Dublin State/Province Dublin 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 to 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 through Learning & Development in-house training mentorship with constant guidance to facilitate career progression. We believe in creating high-performing teams that can exceed our client's expectations regarding the quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.
Minimum Qualification : Science Degree /Engineering degree
Overview: The Plant Quality Assurance (QA) Senior Associate will report to a Senior QA Manager and is a core member of the site QA team.
The QA Snr Associate will act as the Quality point of contact for manufacturing operations and is responsible for oversight of:
Medical Device assembly Serialized Packaging and labelling Skills required: Preferred Traits/Characteristics: Strong attention to detail in terms of task execution and QA review. Proven in Risk Based Decision Making – ability to assess both the impact of an event that occurs and the suggested path forward. Excellent written and verbal communication skills – ability to communicate across different teams/backgrounds & up/down different levels within the organisation. Strong organizational skills, including the ability to follow assignments through to completion – ability to work well on one's own and as part of a dynamic team. Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues Operational Excellence / Continuous improvement experience – ability to identify areas for improvement & implement said improvements. Advising and finding a compliant path forward Ability to do shift work 24/5 (at the moment shift schedule can change according to business needs, notice will of course be provided of any change to the cycle). Requirements Team Responsibilities Purposeful Presence on the floor:
Triage PPOF Pack Checks Audit Walks Quality Review: Logbooks GMP Documentation Batch Records Deviations Protocols Role Responsibilities: Perform all activities in compliance with *** safety standards and standard operating procedures. Observe and provide real-time quality oversight and support for manufacturing on the floor. Perform purposeful presence on the floor audits. Perform manual pack check and deft assessment Perform Batch Review to support customer complaint investigations Provide quality support for triage and investigation of all classes of deviation events. Review/approve deviations for closure ensuring compliance with appropriate standards. Review/approve production batch records, and associated documentation in preparation for qualified person disposition activities. Provide training and advice to staff in order for them to perform their desired functions. Write, review and approve standard operating procedures in accordance with *** policies. Support continuous improvement and operational excellence initiatives Any other tasks/projects assigned as per manager's request.
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