Qualified Person (m/f/x)| North Rhine - Westphalia
In this role you will be responsible for participating in the evaluation and error investigation of quality incidents and initiating correspondence. Performing the function of a QP and participating in the evaluation and approval of Product Quality Reviews and Annual Product Reviews.
Your tasks as "Qualified Person (m/f/x)"
- Batch Record Review (BRR), batch certification and batch release or rejection of market goods (MP) and clinical investigational medicinal products (IMP) taking into account cGMP regulations, legal requirements and the agreements according to the technical agreement in the case of contract manufacturing including related activities.
- Performing the function as a Qualified Person, based on §15 and §19 AMG, §12 (1) AMWHV as well as the EU GMP Guideline Part I esp. 2.2, 2.6 and Annex 16 and Article 51 of Directive 2001/83/EC.
- Participation in the creation, further development, review and approval of Q-documents and SOPs, in particular with regard to the main tasks of BRR, batch certification and batch release.
- Participation in the evaluation and approval of OOS reports, deviation reports, pharmaceutical quality complaints, change control applications and CAPAs.
- Supervision of cross-departmental QA projects as well as participation in the further development of the quality system.
- Participation in the evaluation and error investigation of quality incidents, as well as initiation or participation in corresponding measures such as recalls or market actions.
- Evaluation and implementation of legal requirements of the applicable regulations·
- Participation in the evaluation and approval of Product Quality Reviews /Annual Product Reviews.
Your requirements as a "Qualified Person (m/f/x)"
- Qualification as a Qualified Person according to §14 / §15 AMG
- High quality awareness, a strong sense of responsibility and a solution- and result-oriented approach.
- In-depth knowledge of cGMP and pharmaceutical law (including national, EU and international guidelines such as ICH, WHO, PIC/S and US FDA requirements)
- Business fluent in written and spoken English and German
- Entrepreneurial and cross-functional mindset paired with the joy of living responsibility
- Minimum 5 years of professional experience in the pharmaceutical industry (quality control/quality assurance)
- Confident handling of MS-Office programs and SAP
My contact details:
- Tel: (direct dial) 089 2620 58 895
- LinkedIn: https://www.linkedin.com/in/clodagh-quigg-b150b2200/
I look forward to your application!