About PSC Biotech Ltd

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.

We are looking for candidates who are willing to relocate and work ON AMAZING projects in Ireland.

Responsibilities:

• Perform technical writing, research, and related editing functions to prepare documents, test plans, user cases, project manuals, business proposals, reports, briefings, presentations, guidelines, and other written materials.
• To aid with Change Control process to ensure that change implementation activities and deliverables are coordinated effectively to meet both the TRB and CCB requirements and timelines.
• Help coordinate FMEA sessions with Quality Engineering as needed.
• Assist with attachment and upload of deliverables associated with change control.
• Manages and monitors the change control metrics.
• Ensure accuracy and consistency of the technical/validation documentation.
• Ensure all quality/validation documents are authorized and appropriate compliance approval is gained.
• Update procedures

Requirements:

• Qualification in an appropriate discipline (e.g., Science or Engineering or Information systems)
• Knowledge of regulations associated with the pharma/biotech industry
• Understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectation
• Experience working in a regulated environment would be an advantage
• Expertise in the use of Microsoft Word, Excel and Power Point and electronic document management systems.
• Excellent verbal and written communication skills
• Establishes and manages engagement objectives and expectations, Works independently and/or within team to accomplish job objectives.
• Self-Starter
• Establishes and follows priorities
• Suggest and sometimes may implement innovation and continuous improvement within the technical/validation writing process.
• Builds cross functional and cross-departmental support, fostering overall effectiveness