Associate Specialist

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.

This role requires the delivery of a robust Quality Management System to support a flexible collaborative multiskilled teamwork environment.

The team working style is one of collaboration coaching and facilitation to ensure the success of the site. The Associate Specialist is accountable for the Quality Systems within the site.

Requirements

Primary activities/responsibilities:

Provides to the site knowledge and experience in Quality Systems and/or Operational Quality including the following i.e. Quality Notifications/ Investigations/ Change Management

Uses knowledge to improve Quality Systems solve problems provide continuous improvement and execute tasks.

Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes.

Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.

Supports Corporate Quality to ensure actions related to Quality Systems and/or Operational Quality at the site are executed.

Participation in inspections of Site by Divisional / Regulatory Bodies / third parties together with follow up actions where applicable.

Ensure supply of highquality product through the implementation and oversight of the Quality Management System for the site.

Ensure the highest Quality Compliance and Safety standards.

The Associate Specialist/ Specialist will participate and comply with the client Quality Management System (QMS) requirements including ownership.

The Associate Specialist/ Specialist is accountable for the smooth execution of all appropriate documentation associated within the IPT/QA. He/ She will contribute to the HighPerformance culture within the IPT/QA by providing a flexible accurate service to enable the IPT/QA to achieve client four key priorities.

Is an active member of the cross functional IPT/QA Team providing support guidance and expertise to ensure the success of the IPT/QA.

Will participate and comply with the client Quality Management System (QMS) requirements including ownership.

Primary activities/responsibilities:

Provides to the site knowledge and experience in Quality Documentation Systems.

Responsible for the Site Documentation System including Issuance reconciliation storage archiving and retrieval of cGMP documentation to support the manufacture & testing of our products.

Complete documentation audits.

Coaches and guides colleagues within the site.

Responds to nonstandard requests from customer needs.

Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.

Ensures supply of highquality product through the implementation and oversight of the Quality Documentation System for the site.

Champion the highest Quality and Compliance standards for the site.

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