Associate Specialist

• Industry Pharma/Biotech/Clinical Research
• Work Experience 4-5 years
• City Cork
• State/Province Cork
• Country Ireland

Job Description

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.

This role requires thedelivery of a robust Quality Management System to support a flexible,collaborative, multi-skilled teamwork environment.

Theteam working style is one of collaboration, coaching and facilitation to ensurethe success of the site. The Associate Specialist is accountable for theQuality Systems within the site.

Requirements

Primary activities/responsibilities:

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

· Uses knowledge to improve Quality Systems, solveproblems, provide continuous improvement, and execute tasks.

· Understands and applies regulatory / compliancerequirements to their role together with remaining current on upcomingregulatory and compliance changes.

· Makes decisions within guidelines and policies whichimpact own priorities and allocation of time to meet deadlines.

· Supports Corporate Quality to ensure actions relatedto 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 whereapplicable.

· Ensure supply of high-quality product through theimplementation and oversight of the Quality Management System for the site.

· Ensure the highest Quality, Compliance and Safetystandards.

· The Associate Specialist/ Specialist will participateand comply with the client Quality Management System (QMS) requirements,including ownership.

· The Associate Specialist/ Specialist is accountablefor the smooth execution of all appropriate documentation associated within theIPT/QA. He/ She will contribute to the High-Performance culture within theIPT/QA by providing a flexible, accurate service to enable the IPT/QA toachieve client four key priorities.

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

· Will participate and comply with the client QualityManagement System (QMS) requirements, including ownership.

· Primary activities/responsibilities:

· Provides to the site knowledge and experience inQuality Documentation Systems. ·

· Responsible for the Site Documentation Systemincluding Issuance, reconciliation, storage, archiving and retrieval of cGMPdocumentation to support the manufacture & testing of our products.

· Coaches and guides colleagues within the site.

· Responds to non-standard requests from customer needs.

· Makes decisions within guidelines and policies whichimpact own priorities and allocation of time to meet deadlines.

· Ensures supply of high-quality product through theimplementation and oversight of the Quality Documentation System for thesite.

· Champion the highest Quality and Compliance standardsfor the site.