Qualified Person

Qualified Person

Teil II Primäres Ziel der Stelle / Part II Primary Job Objective

The QP is responsible to manage and lead the product release team in MFG19 which is performing the review of batch related documentation from Manufacturing and Quality Control as well as review of supporting documentation to prepare and enable released by the Qualified Person. The Qualified Person (QP) is responsible for batch certification and release according to the German AMWHV (Arzneimittel- und Wirkstoffherstellungsverordnung) and AMG (Arzneimittelgesetz) as well as the EU-GMP Guidelines following EU-GMP Guide Annex 16 and 13. This includes release of imported Drug Substance/intermediate and bulk for Drug Product manufacturing according to EU-GMP-Guide Annex 21.

Department Description

As Qualified Person you will be joining an organization where people of all backgrounds and experiences are respected and where we work together focused on changing lives. In this role you will report to the German Quality Head.

Teil IV Berufliche Verantwortung / Part IV Job Responsibilities

• Provide technical and managerial leadership to the product release team.
• Oversee the product release process and ensure that related the applied standards and procedures are up to date correct and in accordance with current GMP requirements.
• Ensure review and approval of manufacturing Batch Records and that retention samples of the released batches are taken handled and stored appropriately.
• Act as a Qualified Person (QP) in accordance with Annex 16 and 13 of the EU GMP Guide and provide certification or confirmation for batch release and local regulations (AMG AM /HV).
• Release imported Drug Substance for Drug Product manufacturing according to EU-GMP-Guide Annex 21
• Apply quality oversight (e.g. by document reviews and audits) of the execution and GMP compliance of previous manufacturing steps.
• Ensure compliance with requirements of the manufacturing authorization by interacting with all relevant departments.
• Apply high ethical standards and professional conduct with clients and the authorities.
• Cooperation with Quality Assurance and Regulatory Affairs and other departments to support that an effective pharmaceutical quality management system is operated and that regulatory obligations of WuXi Biologics Germany are fulfilled.
• Collaborate with all relevant department to achieve and contribute to the required quality and GMP compliance.
• Demonstrate expertise regarding Quality Assurance (QA) Good Manufacturing Practice (GMP) including Good Distribution Practice (GDP) and Quality Control (QC) in interactions with clients authorities and internal departments.
• Provide regulatory input related to manufacturing authorization applications renewals variations or other updates as needed.
• Take decisions during recall of products.
• Be part of the investigation team for manufacturing investigations Out-Of-Specification (OOS) investigations and deviation investigations. Participate in change control review board.
• Participate in the Quality Management System by creation and review of documents to ensure compliance with local and EU-GMP requirements related to the following quality topics: (Annual) Product Quality Review Process Validation Analytical Method Validation and Qualification of equipment instruments utilities and facility.
• Perform QP related audits of external suppliers and service providers as required.
• Further QP responsibilities are defined in WX-SOP-01309 GMP responsibilities of Key Personnel and Departments.

Teil III Mindestanforderungen an die Stelle / Part III Minimum Requirements

Bildungshintergrund und Erfahrung / Education Background and Experience

Qualifications:

• The required educational background for obtaining the accreditation as a Qualified Person by the German governmental authority as defined in $15 AMG needs to be fulfilled.

Besondere Kenntnisse / Special Knowledge

• Theoretical and practical knowledge in manufacturing quality control and release of biological and aseptic pharmaceuticals.
• Thorough understanding of pharmaceutical law quality management systems and the professional duties of a QP.
• Medicinal chemistry or biological pharmaceutical knowledge.
• Profound understanding of the manufacture and supply chain.
• Leadership and interpersonal communication skills.
• Fluent in German and English language.
• The ability to well handle pressure make confident judgements and act decisively in case of failures or non-conformances.

Onerous requirements

• Must be willing to travel if required to fulfil the responsibilities of the position.

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WuXi Biologics is an equal opportunities employer.