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Operations Excellence Technical Specialist, Cork
Client:
Location: Cork, Ireland
Job Category: Other
EU work permit required: Yes
Job Reference: b05907e56a31
Job Views: 64
Posted: 21.01.2025
Expiry Date: 07.03.2025
Job Description:
About PSC Biotech
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. 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 to facilitate career progression. We believe in creating high-performing teams that can exceed our client’s expectations regarding quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.
A fantastic opportunity has arisen for an Operations Excellence Technical Specialist. The Technical Specialist will work on the Operations Excellence team, review constraints in the current manufacturing process, and deliver projects that directly combat these constraints.
Requirements
Bring energy, knowledge, and innovation to carry out the following:
* Support the process by holistically reviewing the how and why individual process steps are performed, identifying areas where efficiencies can be made, and leading projects to deliver these efficiencies.
* Manage EHS and Quality investigations and oversee batch record reviews.
* Provide technical support to Operation functions and changes.
* Lead cross-functional problem-solving teams for troubleshooting and investigations within Vaccines IPT.
* Be responsible for the completion of continuous improvement projects to support manufacturing operations through the development of validation schedules, master plans, and validation protocols.
* Apply Lean Six Sigma and Lean methodologies.
* Represent the department on cross-functional project teams.
* Adhere to the highest standards for Compliance (Quality and Safety).
* Ensure compliance with site EHS policy, cGMP, and other business regulations and lead/co-ordinate Technical IPT input to risk assessments, audits, regulatory inspections, and incident investigations.
* Ensure the highest Quality, Compliance, and Safety standards by participating and complying with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.
What skills you will need:
* 5+ years experience in a pharmaceutical or a highly regulated environment.
* B.Sc. Degree or other qualification in Biochemistry, Microbiology, Chemistry, Engineering, or a related field.
* Project management experience in wide-scaled and/or complex projects.
* Strong analytical and problem-solving skills.
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