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Qualified Person

Employer
Hobson Prior
Location
Limerick (County), Munster (IE)
Salary
TBD
Start date
6 Jun 2024
Closing date
6 Jul 2024

View more

Discipline
Quality, Qualified Person
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Our client is a rapidly growing biotech company, with multiple sites in Ireland, and their searching for their next QP. This company has been in Ireland for well over 30 years, showing a longstanding and stable company – ready to continue elevating to the next level.

They recently invested 500 million USD in a brand-new state of the art facility, which a huge focus on digitalization – proving their desire to be a modern company.

The Qualified Person (QP) is essential for guaranteeing the quality and regulatory adherence of the client’s biopharmaceutical products at their cutting-edge manufacturing site. This role involves but is not limited to, overseeing batch approvals and regulatory authorizations. The QP will work with various departments to support technical goals and act as a technical advisor for the site quality assurance teams.

Key Responsibilities:

  • Certify biotech drug substance (DS) batches to ensure compliance with regulations and authorizations.
  • Ensure biotech drug product batches are tested per manufacturing and marketing authorizations.
  • Make final decisions on batch certification.
  • Provide quality leadership, direction, training, and governance.
  • Approve quality-related documents, ensuring compliance with company, GMP, and regulatory requirements.
  • Review and approve GMP documents for qualification and validation.
  • Review and approve other GMP documents such as SOPs, raw material specifications, sampling protocols, master formulas, and process flow documents.
  • Monitor GMP compliance and ensure effective implementation of key GMP programs and systems.
  • Oversee the Site Self-Inspection program and audit production, systems, and service areas for compliance with quality systems, policies, guidelines, and procedures.
  • Issue QP declarations as required.
  • Evaluate and contribute to regulatory information, reviewing and approving dossier sections for product submissions.

Qualifications:

  • BSc, MSc, or PhD in Biology, Chemistry, Pharmacy, or a related discipline.
  • Must be approved by a member state as a licensed QP to be named on the company license.
  • At least 10 years of experience in quality assurance within the relevant industry.
  • Strong knowledge of cGMP, FDA, Data Integrity, Quality Risk Management, and other biopharmaceutical regulatory requirements.

Interviews are currently underway for this role, so I would advise fast action in this case. 

If you have any questions, please feel free to reach out to Billy O'Brien (billy.o'brien@hobsonprior.com). 

 

Company

Providing recruitment solutions across the life sciences industry

Hobson Prior is a leading specialist life sciences recruiter focused on finding and placing outstanding candidates across Europe and the Asia Pacific. We work proactively and with integrity, communicate in a professional and honest manner and invest time to understand and match the exact requirements of our clients and candidates.

Our highly selective clients trust us to source and secure interim and permanent candidates who’ll make a real difference to the success of their business. Our candidates, the best in the industry, often choose to work with us exclusively because we offer the best opportunities in their specialist field.

Representing who we are and what we stand for, our values influence the way we serve our clients and candidates and the way we interact with each other.

We identified them collaboratively – as a team – and so feel 100% invested in them. Together, we think they provide the best possible outcomes all who work with us.

Professional
Our standards are set high. We work to a rigorous set of processes to ensure that our conduct is professional, ethical and delivered with integrity at all times.

Dedicated
We are dedicated to finding the very best solutions for our clients and candidates, always going the extra mile to deliver measureable value.

Experienced
We are guided by our experience and knowledge to provide the best possible service and support to our candidates, clients and colleagues. Our approach is consultative and collaborative.

Specialist
We focus solely on our chosen market, developing expert consultants who know their industry in depth and specialise within it.

Proactive
We find great candidates, developing relationships with them regardless of whether they are actively looking. This means we are able to provide both candidates and clients with unique opportunities.

Ambitious
Driven by results, we have plans to expand across different global regions and markets and have confidence in our ability to grow successfully through our core focus.

Company info
Website
Telephone
01892 612 612
Location
Wellington Gate
7-9 Church Rd
Tunbridge Wells
TN1 1HT
GB

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