Publié dans: Autres dans Glasgow | Posté: |
Qualified Person (QP)
Location: Glasgow
Contract
Job Description
CDM Life Sciences are keen to speak with QP’s with IMP and commercial experience to join our clients growing team on a Contract basis. As a QP, you will be responsible for performing legal and routine duties related to the review, approval, and certification of licensed and investigational products.
Reporting to the Head of Quality, you will maintain effective quality oversight of internal and external contract manufacturing and testing activities to ensure that local and global quality systems/procedures are defined, maintained, and operate effectively in accordance with UK, EU, regulatory requirements.
Duties and Responsibilities:
* Carrying out the duties of a Qualified Person as defined in the Human regulations 2012 and Medicines for Human Use (Clinical Trials) regulation 2004 and EU guide to cGMP.
* Releasing batches according to standard procedure.
* Assessing deviations and taking appropriate action.
* Providing resources for the certification of batches for release to market in compliance with relevant regulations and directives.
* Maintaining an understanding of current and forthcoming legislation impacting pharmaceutical product manufacturing.
* Maintaining an understanding of current product license requirements.
* Developing proposals for efficiency savings in the release process.
* Acting as a point of leadership for discussing product quality issues, providing education, operational support, technical input, and knowledge management to staff.
* Continuously reviewing the batch certification process for compliance, efficiency, and improvement.
* Identifying potential new regulatory requirements and formulating remediation/development proposals.
* Interacting with systems to ensure timely identification, communication, and action on quality and regulatory compliance status.
* Conducting cGMP compliance audits.
* Possessing extensive knowledge of current Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and Good Clinical Practice (GCP).
* Having experience in auditing GMP/GDP/GCP/ISO environments.
* Being familiar with regulatory and ISO inspections.
* Understanding global guidelines for the manufacture of pharmaceutical products.
* Working within Quality Management Systems and understanding their value and compliance aspects within a pharmaceutical company.
* Making data-driven recommendations/decisions and taking appropriate action.
* Having the ability to present effectively to groups.
* Possessing strong influencing skills.
Essential:
* Qualified/Registered to act as QP in the UK
* 5+ years’ experience within a pharma (Clinical/Commercial) batch release role.
* Experience in releasing Investigational Medicinal Products (IMPs), including biologics and sterile products.
To apply or for more information call Richard Hendry on (phone number removed)