Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Stelle: Spezialist Qualitu00e4tskontrolle (m/w/d) Standort: Grou00dfbeeren bei Berlin Abteilung: Qualitu00e4tskontrolle Vorgesetzter: Manager Quality Control Unterstu00fctzung bei der Organisation des Bereiches Qualitu00e4tskontrolle, um sicherzustellen, dass die wichtigsten Prozesse in der Qualitu00e4tskontrolle im Einklang mit den GMP-Standards und den definierten Prozessen des Unternehmens ablaufen. HAUPTAUFGABEN UND VERANTWORTLICHKEITEN: Durchfu00fchrung der Wareneingangskontrolle fu00fcr GMP-Materialien Durchfu00fchrung von produktionsbegleitenden Zwischen- und Endkontrollen Klinischer Pru00fcfmuster, inklusive der Bewertung und Dokumentation von Ergebnissen Erstellung von GMP-relevanten Dokumenten wie SOPs, Spezifikationen, Anweisungen zur Probenahme und von Pru00fcfanweisungen und Abstimmung dieser mit dem Head of Quality sowie Sicherstellung, der Einhaltung der Prozesse im Team Unterstu00fctzung bei der Erstellung, u00dcberpru00fcfung und Genehmigung von Qualifizierungs- und Validierungsdokumenten im GMP-Umfeld als Unterstu00fctzung im Rahmen der Zusammenarbeit der zustu00e4ndigen Fachabteilung und mit der Qualitu00e4tssicherung Durchfu00fchrung und Bewertung von chargenspezifischen Qualitu00e4tskontrollaktivitu00e4ten sowie Pru00fcfung der Chargendokumentation (Batch Record) auf Vollstu00e4ndigkeit, Korrektheit und GMP-Konformitu00e4t hergestellter Chargen (Labeling, Sekundu00e4rverpackung) Mitwirkung bei der Dokumentation, Nachverfolgung und Umsetzung von Change-Control-Mau00dfnahmen sowie Unterstu00fctzung bei der Ursachenanalyse und Risikobewertung Dokumentation, Untersuchung und Bewertung von GxP-relevanten Abweichungen Erarbeitung von CAPA-Mau00dfnahmen und Sicherstellung der rechtzeitigen Umsetzung einschlieu00dflich der zugehu00f6rigen Dokumentation Unterstu00fctzung bei der Durchfu00fchrung der Schulung des Personals, das im Bereich der Qualitu00e4tskontrolle tu00e4tig ist, im Rahmen der Einarbeitung und der fortlaufenden Weiterbildung VORAUSSETZUNGEN: Ausbildung zum PTA (m/w/d), PKA (m/w/d), CTA (m/w/d) ODER Bachelor-Abschluss in Pharma- oder vergleichbaren Wissenschaften Erste einschlu00e4gige Berufserfahrung auf dem Gebiet der pharmazeutischen Qualitu00e4tsontrolle Sehr gute Kenntnisse regulatorischer Anforderungen im GMP- und GDP-Umfeld Gute Kenntnisse im Bereich Abweichungen, CAPAs und Change Control Gute Kenntnisse im Bereich IT-, ERP- und QS-Datenmanagementsysteme sowie sehr gute Expertise in MS Office Flieu00dfende Deutschkenntnisse sowie gute Kenntnisse der Englischen Sprache in Wort und Schrift Freude an der Mitarbeit an einer verantwortungsvollen und sinnhaften Aufgabe im Bereich Klinischer Dienstleistungen und bei der Bereitstellung neuartiger Theapieformen fu00fcr Patient:innen weltweit. Title: Quality Control Specialist Location: Grou00dfbeeren near Berlin, Germany Department: Quality Reporting to: Head of Quality Assist in organizing the Quality Control department to ensure that key quality control processes are conducted in accordance with GMP standards and the companyu2019s established procedures. MAIN TASKS AND REPSONSIBILITIES: Carrying out incoming goods inspections Executing interim inspections and final inspections of clinical trial samples during production, including the evaluation and documentation of results. Preparation / approval of GMP-relevant documents such as SOPs, specifications, sampling instructions and test instructions and ensuring that these are adhered to Support in the preparation, review and approval of qualification and validation documents in the GMP environment in the context of cooperation with the responsible specialist department and quality assurance Assessment and certification of batch-specific quality control activities as well as review of batch documentation (batch record) for completeness, correctness and GMP conformity of manufactured batches (labelling, secondary packaging) Support in creation, tracking and implementation of change control measures as well as support in root cause analysis and risk assessment, in cooperation with quality assurance Examination and evaluation of GxP-relevant deviations Development of CAPA measures and ensuring their timely implementation, including the related documentation Support training of staff working in the area of quality control within the framework of induction and ongoing training QUALIFICATIONS: Vocational training in pharmaceutical or related fields OR completed Bachelor's degree in Pharmaceutical Science, Health Management / Life Science Management Industrial Pharmacy or similar, or corresponding experience of several years in a comparable position. First professional experience in the field of quality assurance, quality control and/or production, ideally in the biotechnological or pharmaceutical industry Very good knowledge of regulatory requirements in the GMP and GDP environment Good knowledge in the area of deviations, CAPAs and change control Good knowledge of IT, ERP and QA data management systems as well as very good expertise in MS Office Fluent German and English, both written and spoken Strong ability to be self-motivated and to build, lead and motivate a small team of employees Enjoy working on a responsible and meaningful task in the field of clinical services and in the provision of novel forms of therapy for patients worldwide. Join us and be part of building the bridge between life changing therapies and patients. Letu2019s talk future (https://pci.com/) Equal Employment Opportunity (EEO) Statement: _PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._ _At PCI, Equity and Inclusion are at the core of our companyu2019s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity u2013 at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._ Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we donu2019t say no, we figure out how. PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled