Technical Writer

Found in: Talent IE C2 - 2 weeks ago

Dublin, Ireland PSC Biotech Ltd Full time

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 of 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 though 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.



Job Title: Technical Writer



Requirements

Overview: The activities performed in the role of Technical Writer include:

 

·        Develop, review and update manufacturing documentation.

·        Ownership of change controls for Manufacturing.

·        Liaise with Manufacturing regarding documentation changes in an effective and timely manner, rolling out one-point lessons where necessary.

·        Maintain awareness and compliance with project timelines.

·        Develop protocols for execution in Manufacturing in support of change controls, deviations & troubleshooting investigations with support from relevant SMEs.

·        Support execution of protocols as required by project.

·        Involvement in projects as part of continuous process improvement and / or troubleshooting,

·        Liaise with Quality Assurance to ensure that GMP standards are maintained in line with current OS.

·        Support production support team in reducing document turnaround times.

·        Use specified software packages and standard procedures, responsible for compiling and maintaining all relevant documentation including SOPs, APPXs, TRNQs.

·        Provide technical and clerical support to the manufacturing teams in the preparation of documentation, collation of data and tracking of SOPs.

·        Ownership of minor deviations as required.

 

Basic Qualifications:

·        Educated to degree level or equivalent.

·        Experience in Chemistry/Microbiology/Engineering/Validation gained within a biotech, pharma, or health care organisation.



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