Qualified Person IMP (contract) - Dublin
|Job Title:||Qualified Person IMP (contract) - Dublin|
|Location:||Dublin, Republic of Ireland|
|Contact Name:||Nathan Wilson|
|Job Published:||September 07, 2017 09:31|
To act as a Qualified Person (QP) named on Manufacturing and Import Authorization (MIA) for Investigational Medicinal Products under the direction of the Head of GMP Clinical QA with responsibility for investigational medicinal products in accordance with their Clinical Trial Authorizations (national or European), their Investigational Medicinal Products Dossiers and their Manufacturing Authorizations and the principles and guidelines of GMP and in accordance with principles and the detailed guidelines of Good Manufacturing Practice for Medicinal Products (The Rules Governing Medicinal Products in The European Community, Volume IV).
The individual will provide QA /QP support for work performed at contract manufacturers and analytical laboratories, and coordinate priorities and workload with key stakeholders. The individual will be responsible for the successful, timely completion of goals and objectives which will strengthen EU GMP Clinical QA operations.
- To certify that batches of finished products to be released by in the EC/EEA have been manufactured and checked in accordance with the Clinical Trials Authorization (CTA), GMP, Product Specification File and legal requirements as set out in Article 51 of directive 2001/83/EC and article 13.3 of 2001/20/EC.
- To assure drug product, documentation, and data related to the manufacturing, packaging, labeling, and testing of IMPs are compliant with all GMP, SOP, CTA, and regulatory requirements.
- To audit Contractor/Supplier facilities associated with released products, when required to ensure they have effective quality systems in place to assure compliance with the principles of GMP, as laid down in the relevant EC or national laws and guidelines
- To foster communication with key stakeholders in order to properly plan and prioritize workload and to coordinate technical information and queries. To coordinate and participate in meetings that support of department objectives. Foster the use of the Project Based Approach to record all documents that are needed to release material for a clinical study.
- To ensure deviations and OOS investigations are adequately investigated and documented. To ensure clinical complaints are adequately investigated and reported.
Education & Experience Requirements
- Eligibility to act as a Qualified Person in line with local and EU directives
- Bachelor's degree in chemistry, biology, pharmacy or a related science discipline
- Experience working in Quality Assurance supporting the manufacturing / packaging of drugs, biologics, or devices.
- Working knowledge and understanding of quality systems and GMPs.
- Operational experience and technical understanding of standard manufacturing and packaging processes for a variety of dosage forms
- Experience working with ERP applications
- Must be able to read, understand, speak and write technically and legibly in English
- Must be able to critically evaluate completed manufacturing documentation and assess to determine compliance with SOPs and clinical trial authorizations
- Experience working with contract manufacturing organisations
- GMP Auditing experience
- Experience interfacing with regulatory bodies or working on regulatory submissions.
- High level of professional competence. Preferably demonstrated by objective certification (e.g. Certified Quality Auditor or Engineer).
Key Skills and Competencies
- Careful attention to detail
- Articulate, computer literate, good analytical, problem solving, decision taking, inter-personal and influencing skills.
Other job components
- Evaluation of batches assessing impact to safety, identity, strength, quality, or purity
- Evaluation of changes to regulatory filings and/or validated systems
- Knowledge of QP function, Manufacturing/Wholesaler Authorisations, Marketing Authorisations
- Clinical and commercial supply chains
- Good technical and QA background having a good understanding of method development and validation, specification setting
- Communicate effectively with contractors for technical information
- Good technical and QA background having a good understanding of drug product development.
Internal and External Contacts
- Global Quality Assurance
- Quality Control
- Clinical Supply Chain & Customer Service
- Regulatory Affairs
- Pharmaceutical and Analytical Development
- Process Development
- Contract Manufacturers
- Contract Laboratories
- Some travel required for audits and other quality related visits. Some overseas travel maybe required.
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