QP - Qualified Person
This vacancy is published by an accredited employer with authorized corporate payroll and standard compliance adherence.
Transatlantic Cost of Living & Purchasing Power Benchmark
Position Overview & Specifications
CAI is a 100% employee-owned company established in 1996, that has grown year over year to nearly 700 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.
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.
- We act with integrity,
- We serve each other,
- We serve society,
- We work for our future.
We are now seeking a Qualified Person (QP) to join our growing operations in the UK. The role of a QP in CAI is to:
- 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.
Position Requirements:
- 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.
Candidate Selection & Onboarding Process
Application & Resume Screening
Submit your tailored CV/Resume directly to the talent acquisition portal.
Technical & Competency Interviews
Virtual interviews with the hiring manager and multidisciplinary team.
Formal Offer & Benefits Negotiation
Written agreement outlining compensation, equity, retirement vesting, and relocation allowances.
Onboarding & Corporate Integration
Equipment provisioning, team orientation, and commencement of duties.
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QP - Qualified Person • CAI
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