About the Role:
The company is seeking an experienced Qualified Person to join their team. This is a fantastic opportunity for an individual with relevant qualifications and experience to take on a permanent role.
The Qualified Person will be responsible for undertaking the duties as defined in relevant regulatory directives. This includes responsibility and performance of Batch Certification and Release of drug product in accordance with requirements of EU Directives and GMP.
The ideal candidate will have a relevant degree qualification, preferably in Chemistry, Pharmacy or Biological Science. They will also have experience with FDA, MHRA, EMA and other regulatory agencies, prior experience in a pharmaceutical manufacturing environment, and extensive audit experience.
* Key Responsibilities:
* 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 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 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.
About You:
To be successful in this role, you will need to have:
* 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.
* Extensive audit experience.
* Ability to travel for audits (occasional)
What We Offer:
We offer a competitive salary and benefits package. Hybrid working options are available.