Technical Writer

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 cloudbased 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 likeminded 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 diversecultural work setting.

Employee Value Proposition

Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development inhouse 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 onepoint 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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