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Biotech Process Specialist

3 weeks ago

Dublin, Dublin City, Ireland PSC Biotech Full time
Job Description

PSC Biotech is a leading biotech consultancy firm founded in 1996. We provide cloud-based software solutions for quality management and regulatory inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

About the Role

This role involves working as a key team member within the Downstream Integrated Process Team (IPT) to ensure on-time delivery of the production schedule while maintaining alignment with site safety and quality standards.

The ideal candidate will have experience across multiple site functions, including quality, engineering, or supply chain, and be proficient in technical writing for GMP documentation and quality investigations.

Key Responsibilities

* Provide oversight on material management, ensuring quality and delivery metrics related to material management are always maintained.
* Own Quality Investigation from identification through root cause analysis.
* Provide oversight on day-to-day production quality metrics ensuring on-time documentation closure, line clearance, and material management as per area SOPs.
* Drive continuous improvement projects related to schedule, equipment, and delivery capability within the DS IPT.
* Act as a link between the shift operations team and day team, ensuring standardization and integration between all IPT teams.
* Support audit readiness in the BDS and drive a permanent audit readiness culture within the team.

Requirements

* A Level 7 Degree in Science, Engineering, or other relevant disciplines/relevant experience preferable.
* Experience in change management in a GMP environment.
* Excellent verbal and written communication skills.
* Proficient in Microsoft Office Tools (Word/Excel/PowerPoint).
* Ability to work independently and as part of a team in a cross-functional collaborative environment.
* High level of attention to detail.
* Good interpersonal skills.