Qp – Qualified Person
Posted on 7/19/2023
INACTIVE
CAI

1,001-5,000 employees

Integrated services
Company Overview
CAI brings top-tier expertise to every stage of a project, from creating comprehensive, detailed project plans to achieving full-scale production operations, into rigorous asset management, reliability, and sustainability activities.
Consulting

Company Stage

Pre-seed

Total Funding

$3.4M

Founded

1996

Headquarters

Indianapolis, Indiana

Growth & Insights
Headcount

6 month growth

2%

1 year growth

17%

2 year growth

33%
Locations
London, UK
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Communications
Quality Assurance (QA)
Marketing
Customer Service
CategoriesNew
Customer Success & Support
Requirements
  • To ensure the QMS is maintained to corporate and international guidelines and changing regulatory guidelines
  • To ensure that the site is audit ready
  • To assure that all implemented procedures are followed on the site, according to each product requirements
  • To manage all quality activities for the products assigned
  • To promote the importance of high-quality levels and the importance of a continuous improvement culture in all core company activities
  • Approves quality related documentation (operational areas auxiliary documentation - e.g. Cleaning protocols)
  • Reviewer of quality related documentation (generated by the operational areas - e.g.: Batch Production Records)
  • Assesses and approves Major and minor Change controls and procedures
  • Assesses and approves deviations; QA Specialist is equivalent to Group leader for purposes of deviation approval
  • Release of API, intermediates, and excipients (provided minimum training and experience levels have been achieved per site procedures)
  • To release medicinal products, investigational medicinal products, Drug substances and excipients manufactured, in order to assure that current Good Manufacturing Practices and provisions of the marketing authorization/ product specification file are applied
  • To ensure that the site manufacturers authorization (MIA) and Active Substance Register (ASR) are updated as required
  • To communicate regulatory requirements to the different areas of the company and Health Authorities as required
  • Participate in cross functional investigations of deviations and change controls and advise on corrective actions and assist with their implementation as appropriate
  • Notify the Health Products Regulatory Authority (HPRA) of potential recall if a product issue is of sufficient magnitude to affect the quality/ safety or efficacy of the product
  • Foster an environment of Continuous Quality Improvement by identifying and implementing practices to deliver, quality, efficiency and service level improvements
  • Act as key contact for medicinal products and investigational medicinal products regulatory inspections
  • BS or MS in a relevant science or engineering field, or equivalent
  • 10+ years QP/Quality experience in the Pharma industry
  • Excellent oral and written communication skills
  • Excellent problem-solving skills
  • Customer-service focused
  • Able to travel domestically and internationally if required
Responsibilities
  • Our approach is simple; we put the client's interests first, we do not stop until it is right, and we will do whatever it takes to get there
  • As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally: