Operations Compliance Specialist

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

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.

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.

Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development through 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.

Reporting to the Inspection Readiness Lead, the Operations Compliance Specialist is responsible for all aspects of Documentation Management & Compliance.

• Manage the authoring & drafting of all types of Manufacturing Operations documentation.
• Specifications & associated forms in conjunction with the various departmental subject matter experts (SME)
• Support document updates and manage timelines for cross‑functional Projects.
• Act as a SME/Superuser on the Controlled Document System to facilitate the processing & approval of documents.
• Organise & Facilitate Document Round Table meetings with cross functional teams as required
• Mange and build Quality Veeva QMS metrics for Manufacturing Operations
• Coach & Train colleagues in Documentation System & GDP queries
• Support manufacturing operations on meeting deadlines on Veeva QMS records
• Update compliance procedures and processes.

• Generate Reports/Metrics & analyze trends as required including but not limited to:
• Perform Logbook Training, review, and trending of all closed logbooks, identifying issues and managing timely archiving.
• Train and perform Area Self Inspections & Generate ASI schedule.
• Train Manufacturing colleagues in GDP/GMP
• Management of Veeva paper Binders
• Continuous monitoring of Compliance in Manufacturing.
• Facilitate all internal and external Inspections.
• Participate in permanent inspection readiness by completing Inspection walkthroughs within manufacturing operations.
• Collaborating with Global colleagues (as required) including but not limited to:
  Supplier Change Notifications, EDMS & Managerial Data Management
• Management of Job Description s & New Hire Checklist and Assigning Lockers.
• Be proactive & collaborative in troubleshooting & resolving issues with documentation, training & systems collaborating with different departments across the site.
• Engage in Continuous Improvement Initiatives
• Manage compliance projects and Inspection readiness updates.
• Apply aligned Operations Compliance Specialist role skills across Drug Substance, Drug Product and Packaging.

• 2+ years’ experience in technical writing and compliance
• Proficient in data analytics, data visualization
• Working knowledge in Regulations, GMP, GDP
• 2+ working within a regulated healthcare industry including a role in capacity of quality and compliance.
• Strong verbal, written and oral communication skills.
• Able to work independently and be flexible to changing priorities