Qualified Person (QP) - (m/w/d) at Lilly

Alzey, Rhineland-Palatinate, Germany -

Full Time

Start Date

Immediate

Expiry Date

06 Feb, 26

Salary

0.0

Posted On

08 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Pharmacy, Quality Assurance, Regulatory Monitoring, GMP, Leadership, Decision-Making, Pharmaceutical Legislation, Quality Management Systems, Analytical Skills, Communication, Technical Support, Audit, Change Management, Batch Certification, Compliance, Problem Solving

Industry

Pharmaceutical Manufacturing

Description

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. At Lilly in Germany, we are currently planning and building a high-tech production facility in Alzey (Rhineland-Palatinate), which will expand our production of injectable drugs from 2027 and employ up to 1,000 specialists. To make the most of our innovative production site, we are looking for motivated reinforcements who, together with us, will ensure the supply of Lilly medicines in Germany, Europe, and worldwide, in line with the three Lilly values of "Excellence," "Integrity," and "Respect for People." Join our Lilly team in Alzey and start as soon as possible as: Qualified Person (QP) - (m/w/d) What tasks await you? Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. As a result, Lilly is looking for an experienced Qualified Person (QP) to support our growth in Alzey, Germany. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies. The QP is responsible for certifying that each batch of a medicinal product meets all required provisions when released from a manufacturing facility. These provisions include ensuring that the batch has been produced according to appropriate standards and has successfully passed all required tests. Certification and Release of Finished Batches Confirms, certifies, and releases batches of products manufactured, ensuring all manufacturing steps have been performed in compliance with GMP, the marketing authorization of the relevant product, defined procedures, and current regulations. Confirms batches of products intended for clinical trials. Approves batch certificates. In case of non-compliance detected at their level, decides on necessary actions. Ensures periodic monitoring of the quality review activity for semi-finished Quality and Regulatory Monitoring Continuously updates knowledge by staying informed of technical, regulatory, and scientific developments. May consult regulatory dossiers for the marketing authorization of products they confirm, certify, and release. May consult quality contracts necessary for the confirmation, certification, and release of product batches, and participates in their updates. Ensures documented oversight of imported products and active substances. Quality Assurance Performs analysis of corporate standards and participates in their implementation on site. Participates in the implementation of new regulations. Acts as approver and/or reviewer of procedural documents related to their activity. Approves regulatory specifications of manufactured products in the LIMS system. Approves in SAP the list of countries registered for finished product codes. Acts as reviewer for the Annual Product Review (APR) of the Fegersheim site, ensuring the quality of the analysis and conclusions. Conducts impact analyses in the change management system related to their area of expertise. Verifies the application of the quality system in and outside the quality department (especially through audits). Responsible for the annual stability strategy on site. Responsible for the annual visual inspection strategy on site. Approves stability protocols. Represents Quality Assurance at the monthly CCRC Committee. Communicates with subsidiaries/other manufacturing sites regarding the decision to quarantine already shipped batches. Prepares ANIRs (Additional New Information Reports) as part of Annual Reports (e.g., US, Mexico, etc.). Technical Support May be responsible for implementing changes related to their activity. Conducts impact analyses of change controls related to their area of expertise. May review/approve deviations and change controls. Participates in the major deviations and change controls committee. Reviews quality contracts with suppliers (active ingredients), subcontractors, and clients (Lilly subsidiaries and external clients). Coordinates batch traceability requests. Coordinates with the delegated pharmacist for batch recall simulation exercises. May participate in Rapid Investigation Groups (GIR) in case of major investigations. Conducts regulatory monitoring to maintain site compliance with pharmacopoeias (outside the laboratory): analyzes publications, communicates changes to relevant departments. Drafts and is responsible for submitting the status report and teledeclaration of MPUPs (pharmaceutical raw materials) to the ANSM. Determines the need to submit Modification Requests for the pharmaceutical establishment to the ANSM. Drafts Modification Requests for the pharmaceutical establishment. Collaborates with the Responsible Pharmacist, QPs from the affiliates to verify the accuracy and relevance of data submitted to Authorities. Audit/Inspection Conducts or participates in internal audits according to the program defined by the internal quality audit manager and follows up on action plans. May participate in and/or prepare quality audits at suppliers/subcontractors/France subsidiary as per the defined program. Interacts directly with auditors/inspectors during audits/inspections concerning their area of expertise. Acts as a member of the escort/documentation room/preparation room during audits/inspections. May coordinate the drafting of responses to audit/inspection observations. How do you convince us? Completed degree in pharmacy and licensure as pharmacist; Expert knowledge as per §15 of German Medicinal Products Act (Arzneimittelgesetz, AMG) Qualified Person as per §14 of the German Medicinal Products Act (EU Qualified Person) If applicable: Supervision of an adequate importation process of medicinal products from non-EU countries in compliance with §72 of the German Medicinal Products Act (AMG) and the EU GMP Annex 21 At least two years' practical experience in the field of qualitative and quantitative analysis and other quality testing of medicinal products (i.e. Expert Knowledge as per §15 AMG). Fluent in spoken and written German and English Additional Skills/Preferences: Profound knowledge of applicable national and European drug legislation, cGMP/GDP guidelines as well as relevant national and international requirements of pharmaceutical industry with focus on distribution of medicinal products Profound knowledge of importation requirements from third countries into the European Union as per EU GMP Annex 21 and Union Customs Code (UCC) as well as testing & release requirements as per EU GMP Annex 16 In-depth knowledge of pharmaceutical legislation, quality management systems, and the professional obligations of a quality manager. Good understanding of pharmaceutical manufacturing and supply chain. Leadership skills. Decision-making ability. Additional Information: Primary location is Alzey, Germany On-site presence required Ability to travel (approximately 10-20 %) May be required to respond to operational issues outside of core business hours and days (on-call duty) What can you look forward to with us? Pioneering spirit: Become part of a team of specialized professionals that will grow to up to 1,000 colleagues over the next three years. Innovation: You will work in a medical high-tech production facility equipped with the most advanced technology. Creative freedom: From the beginning, you will have the freedom to contribute your ideas and implement them in cross-functional teams. Development: We value the individual career development of our employees and ensure fair access to professional development worldwide through our "Corporate Lilly University." Financial benefits: In addition to your attractive salary, we offer you the option of an excellent company pension plan and other individual benefits. Have we piqued your interest? Then please apply online with your complete application documents through our applicant portal. We look forward to your application! Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. #WeAreLilly

Responsibilities

The Qualified Person (QP) is responsible for certifying that each batch of a medicinal product meets all required provisions when released from a manufacturing facility. This includes ensuring compliance with GMP, marketing authorization, and conducting quality assurance activities.