TPM and Technical Transfer Sr.QA Manager-EMEA
Annonce d’Emploi : TPM and Technical Transfer Sr. QA Manager – EMEA
Présentation de l’Entreprise
Abbott est un leader mondial de la santé, engagé à créer des solutions scientifiques révolutionnaires pour améliorer la santé des individus. L’entreprise se concentre sur l’anticipation des évolutions des sciences médicales et des technologies. Travailler chez Abbott, c’est participer à un environnement où la croissance personnelle et professionnelle est encouragée, permettant d’allier vie personnelle et développement professionnel.
Opportunité Professionnelle
En tant que TPM and Technical Transfer Sr. QA Manager – EMEA, vous serez basé à Istanbul au sein de la division EPD Established Pharma. Ce rôle vise à assurer la gestion du TPM (Third Party Manufacturer) et à fournir un soutien technique afin de garantir l’approvisionnement en produits sûrs et de qualité.
Missions Principales
Les responsabilités du poste incluent :
- Offrir un soutien qualité pour garantir que les produits fournis respectent les normes cGMP (current Good Manufacturing Practices) et les réglementations en vigueur.
- Développer des plans d’amélioration de la qualité pour les TPM en cas de nécessité.
- Gérer les activités liées aux TPM avec un accent sur l’amélioration continue.
- Surveiller les performances qualité des TPM et veiller à la conformité par rapport aux accords techniques de qualité.
- Coordonner les accords techniques de qualité et leurs révisions périodiques.
- Être le point de contact principal pour les questions de qualité concernant les TPM.
- Fournir un soutien lors des enquêtes, des plaintes, et des actions correctives.
- Maintenir la liste des fournisseurs approuvés des TPM.
Exigences du Poste
Les candidats doivent posséder :
- Un diplôme de niveau licence en science ou en pharmacie.
- Un minimum de 10 ans d’expérience dans l’industrie pharmaceutique.
- Une compréhension approfondie des opérations de production et de test pharmaceutiques.
- Des compétences en communication et en rédaction de rapports en anglais et en français.
- Un bon leadership et des compétences en planification stratégique.
Qualifications Préférées
Des qualifications additionnelles incluent :
- Une expertise en exigences cGMP et en gestion de la qualité pour divers types de produits.
- Certifications telles que IRCA Lead Auditor ou formations en conformité GMP/GDP.
Égalité des Chances
Abbott se positionne en tant qu’employeur offrant des opportunités égales, favorisant la diversité au sein de ses équipes. Les candidats sont encouragés à postuler, quelle que soit leur origine.
Postuler Maintenant
Pour ceux qui souhaitent suivre leurs aspirations professionnelles au sein d’une entreprise qui valorise la diversité et l’inclusion, une candidature peut être soumise via le lien suivant : Postulez dès maintenant !.
Note Finale
La base salariale pour ce poste n’est pas spécifiée. Les candidats sont invités à faire part de leur application en précisant la source de l’annonce. Ce poste se situe dans un environnement crucial pour la santé publique, visant à garantir que les médicaments de qualité soient accessibles à un plus grand nombre de personnes.
📅 Date de publication de l’offre : Wed, 21 May 2025 00:46:03 GMT
🏢 Entreprise :
📍 Lieu : İstanbul
💼 Intitulé du poste : TPM and Technical Transfer Sr.QA Manager-EMEA
💶 Rémunération proposée :
📝 Description du poste : JOB DESCRIPTION:TPM and Technical Transfer Sr.QA Manager- EMEAAbout AbbottAbbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.Working at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
The OpportunityAs TPM and Technical Transfer Sr.QA Manager- EMEA, you’ll be responsible for TPM Management and Product Transfer and Technical Support for assigned TPMs.This position works at Istanbul location in the Established Pharmaceutical Division, where we are committed to bringing the benefits of our trusted medicines to more people in the world’s fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women’s health, cardiometabolic, pain management/central nervous system, and respiratory.As the TPM Sr.QA Manager, you’ll be responsible for:
- Providing QA support for assigned TPM’s to ensure that safe, efficacious, and quality product can be supplied to Abbott to meet cGMP and other applicable regulatory standards and the appropriate market requirements.
- Responsible for development of Quality Improvement Plan for TPMs remediations, when required.
- Managing TPM activities while driving continuous improvement for TPMs.
- Responsible for Monitoring quality performance for assigned TPMs and ensure requirements per Quality Technical Agreements are adhered / followed by assigned TPMs
- Leading Quality Technical Agreements approval and periodic review
- Primary contact for communication of TPM Quality issues as needed.
- QA support for investigations, trends, complaints, corrective and preventive actions (CAPA), validation support, and product release issues as needed.
- Responsible for maintaining TPM Approved Supplier Listing.
- Responsible for supporting Quality Compliance and improvement initiatives.
- Support new contract manufacturing site approvals must approve all new contract manufacturers for EPD commercial product within responsibility.
- QA Lead for investigations, trends, complaints, corrective and preventive actions (CAPA), validation support, product release issues, PQR review and change control at TPM sites
- QA lead for co-ordination with TPMs and internal cross functional team as support and interfaces for routine Quality requirements like GMP audits, new projects or initiatives.
- Analyzes data, makes decisions or provides recommendations to senior staff regarding quality related issues & crises. Work cross functionally in identifying and resolving technical issues across different EPD regions.
- Recommends and implements changes to the system as the result of changing regulations and/or business needs.
- Coordinates across functional areas, business units, and/or geographies in order to achieve the impact goals.
As Product Technology Transfer Sr.QA ManagerAct as QA Lead for below quality activities during Product Technology Transfer
- Leading the initiation and implementation of Change Control / Stability and Change Impact Assessment.
- Test Method Transfer/Analytical Method Validation/Verification.
- Process Validation/Verification Program
- First lot quality review for release the validation batches for commercialization.
- Gather information from the Sending Unit, in order to assemble a data package.
- Evaluate the information gathered and document findings with respect to product robustness.
- Participate to the process of creation, approval and continuous improvement of the regulatory documentation related to EPD products. Provide support for the specification setting to Regulatory Affairs and receiving unit.
- Provide contributions for the Product technical knowledge during and after technology transfer and ensure the product meeting the Quality Standards. Facilitate issue resolution for key investigation and compliance issues
- Involve in support the quality aspects of the Product Portfolio Expansion, Geographic Expansion initiatives NPI (New Product Introduction) and other Non-Centrally Supported Products.
- Ensure that projects and technical activities associated with Drug Substances, Drug Products, Intermediates and non-pharma products (food supplement, medical device, cosmetics) are carried out without business interruptions and according to legal and Abbott Quality, Regulatory and business requirements.
- Liaison between sites QA, commercial affiliates, MS&T (Manufacturing Science and Technology), Operation, Regulatory and other groups as necessary.
- Serve as quality technical resource of regional EPD Quality organization during process and regulatory deficiency issues, risk assessment target cost initiatives and other continues improvement initiatives.
Required Qualifications
- Bachelor’s degree in science, Pharmacy or equivalent level of education at a relevant scientific discipline
- Minimum 10 years of experience in the pharmaceutical manufacturing field (Quality, production, technical support,etc)
- Comprehensive understanding of a wide range of Pharmaceutical Manufacturing and Testing Operations
- Knowledge of international and local quality system and compliance legislations and standards
- GMP/GLP/GCP background related to medicinal products, medical device, food supplement Biotechnological, Biosimilars and Biologics
- Good communication and report writing skills in English and French.
- Strong leadership skills in bringing the best out of people, managing work teams and fostering teamwork within the department.
- Strong strategic Planning/ Thinking, decisive judgement, and Implementation skills.
- Flexible for Travel: 30 %
Preferred Qualifications
- Highly skilled on cGMP requirements and Quality Assurance / Quality Control manager for solid, liquid, injectable and biosimilar products.
- High capabilities in time management, negotiation skills, multi-tasking, communication skills and Microsoft offices.
- Other qualifications/certifications: IRCA Lead Auditor Certification, Auditor Certification Training, Complaint Certification , GMP-GDP Training. Highly skilled on cGMP requirements, team management, and Quality Assurance / Quality Control manager for solid and injectable products.
Apply NowFollow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.The base pay for this position isN/AIn specific locations, the pay range may vary from the range posted.JOB FAMILY:Operations QualityDIVISION:EPD Established PharmaLOCATION:Turkey
Istanbul : Saray Mah Dr Adnan Buyukdeniz Cd UmraniyeADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:Not specifiedMEDICAL SURVEILLANCE:Not ApplicableSIGNIFICANT WORK ACTIVITIES:Not ApplicableTo help us track our recruitment effort, please indicate in your cover/motivation letter where (vacanciesinturkey.com) you saw this job posting.
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