Scientific Technical Specialist
Scientific Technical Specialist
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Job Description
About PSC Biotech
Who are we
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 point 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.
Overview:
Scientific Specialist supporting the downstream operations team. Successful candidate will be part of a Technical Operations team supporting Operations
Requirements
Role Functions:
- Individual will hold the position of risk lead of the contamination control and downstream QRA (quality risk assessments involves owning all pre work holding and leading reviews sessions with interdisciplinary teams and owning the update and approval of the QRA on the electronic GMP system)
- Responsible for Downstream Quality Risk Assessments (QRAs) including contamination control QRAs Responsibility for the timely accurate and efficient management of documents including access and revision control.
- Hold the position of QRA contributor to other risks assessments on site.
- Manage Live Documentation updates from the operations floor.
- Turnaround and issue documentation as per Operations Schedule
- Manage and implement on the floor documentation control system.
- Drive the Documentation Life Cycle System to ensure documents are approved in as per Scheduling requirements.
- Work with various Subject Matter Experts to ensure technical documentation updates are approved.
- Creation and revision of Standard operating Procedures (SOPs) Work Instructions (WI s) as required
- Work closely with QA Supply chain and Operations core functions
- Ensure compliance with all regulatory GMP Safety and Environmental requirements.
Key Competencies & Experience:
- Selfmotivated with excellent organizational skills
- Experience Working in a Pharmaceutical GMP regulated industry.
- Excellent verbal and written communication skills
- Ability to work independently and as part of a team in a cross functional collaborative environment.
- High level of attention to detail
- Experience working with GMP Documentation Management Systems
- Proficient in Microsoft Office Tools (word/excel/PowerPoint)
- Good interpersonal skills
Qualifications:
- At minimum Degree in a relevant Qualification and Biopharmaceutical experience
At minimum, Degree in a relevant Qualification and Biopharmaceutical experience Scientific Specialist supporting the downstream operations team. Successful candidate will be part of a Technical Operations team supporting Operations
Education
At minimum, Degree in a relevant Qualification and Biopharmaceutical experience Scientific Specialist supporting the downstream operations team. Successful candidate will be part of a Technical Operations team supporting Operations
Employment Type
Full Time
