Qualified Person (QP)

JR United Kingdom; South Kesteven; On-site; GBP 50,000 - 80,000; Full time

Job summary

An exciting opportunity has arisen for a Qualified Person to join a dynamic team at a forward-thinking company. This permanent role offers a chance to play a crucial part in ensuring compliance with Good Manufacturing Practices and regulatory standards. As the company expands, you will be responsible for batch certification and product release, working closely with quality management to uphold the highest standards. The position also allows for hybrid working options, providing flexibility while contributing to a vital role in the pharmaceutical industry. If you're passionate about quality assurance and compliance, this role is perfect for you.

Qualifications

• Eligible to undertake Qualified Person duties with relevant degree.
• Experience with FDA, MHRA, EMA, and regulatory agencies.

Responsibilities

• Perform Batch Certification and Release of drug products per EU Directives.
• Ensure compliance with GMP and regulatory requirements.

Skills

Qualified Person duties

Good Manufacturing Practice (GMP)

Quality Management Systems

Regulatory compliance

Auditing skills

Education

Degree in Chemistry

Degree in Pharmacy

Degree in Biological Science

Job description

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SRG's client are looking for an experienced Qualified Person (QP) to join them on a permanent basis at an exciting time for the business as they continue to expand.

This is a fantastic opportunity for an experienced QP to take on a permanent role with excellent salary and benefits.

Hybrid working options are available.

The role:

• Undertake the duties of a Qualified Person as defined in relevant regulatory directives.
• Responsibility and performance of Batch Certification and Release of drug product in accordance with requirements of EU Directives and GMP.
• Ensure products have been manufactured and tested in accordance with Good Manufacturing Practice (cGMP).
• Ensure products manufactured demonstrate compliance with the regulatory requirements.
• Working with the Quality Director and site management to ensure that GMP compliance is implemented and maintained in accordance with the appropriate legislation, company policies/procedures, and in compliance with appropriate manufacturing authorizations.
• Review and implement Quality Management Systems in compliance with current GMP and any regulatory updates or observation. Maintain product quality and release by enforcing quality assurance policies and procedures and GMP requirements.
• Act as a Subject Matter Expert (SME) to facilitate site compliance with the company’s Quality Management Systems. Support the Quality Assurance department for all compliance inspections of the site e.g. internal audits as well as Regulatory Inspections.
• Perform external audits and support the self-inspection schedule for the Company. Maintain knowledge of current guidelines and regulatory advancement in line with the role for continued professional development.

The person:

• Eligible to undertake the duties of a Qualified Person.
• A relevant degree qualification (preferably in Chemistry, Pharmacy, or Biological Science).
• Experience with FDA, MHRA, EMA, and other regulatory agencies.
• Prior experience in a pharmaceutical manufacturing environment.
• Experience in commercial and Investigational medicinal product (IMP).
• Experience in steriles, biologics, ideally with advanced therapeutics and experience being on the licences for these products.
• Ability to travel for audits (occasional).