Abbott is a global healthcare company committed to helping people live not just longer, but better. We employ around over 100,000 people in 150+ countries with a diverse portfolio spanning pharmaceuticals, nutrition, diagnostics and devices. At Abbott, you have the opportunity to make a positive impact on the world through challenging and rewarding work as part of a highly successful and trusted organization that is shaping the future of health. Realize your potential! **Purpose of Rôle** + Management of TPMs and Technology transfer activities at TPMs in EMEA region. + Support new product launches, new product introductions, GeoEx of existing products from one country to another within EMEA region with activation of new upcoming TPMs into EMEA from portfolio growth. **Minimum Education Qualification for the role** Bachelor’s degree in science; Pharmacy or microbiology or equivalent level of education at a relevant scientific discipline or other technical/scientific, or industry experience with enough exposure to pharmaceutical or related industries **Minimum Experience/ background for the role** Total combined years: Combined 12+ years in QA, Operations or Pharmaceutical engineering. Minimum 10 years in pharmaceutical manufacturing plant and minimum 5 years of experience in Quality Assurance / Quality Control function / department. Comprehensive understanding of a wide range of Pharmaceutical Manufacturing and Testing Operations. Knowledge of international and local quality system and compliance legislations and standards. Highly skilled on cGMP requirements and Quality Assurance / Quality Control manager for solid and injectable products. High capabilities in time management, negotiation skills, multi-tasking, communication skills and Microsoft offices. Build Organization & inspire people. **Core Responsibilities** 1- **As TPM QA** + Quality management, oversight at TPM in the EMEA region, for delivering quality products through reliable supply chain with on-site visits on set frequency and business needs. + Responsible to support establishing and implementing management processes at Third Party of medicinal products, medical devices & consumer health products per Regulatory & Abbott EPD contractual requirements. + QA lead in new product introductions meetings and localization projects for smooth execution and launches from contract manufacturing sites from product acquisition, in-licensing deals and or distribution deals. + Responsible for monitoring quality performance for assigned TPMs and ensure requirements per Quality Technical agreements are adhered / followed by assigned TPMs. + 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. + Primary contact for communication / resolution of TPM quality issues and management elevation as needed. + Responsible for updating and maintenance of regional approved supplier listing. **As Tech transfer QA** **2.1 Product Transfer:** + QA Lead for below quality activities during Product transfer including, + Technology Transfer plan + Test Method Transfer/Analytical Method + Validation/Verification + Process Validation/verification Program. + Stability program during Shelf-Life of the product Microbiological validation studies + First lot quality review for release the validation batches for commercialization. + Gather information from the Sending Unit, in order to assemble a data package. **As Tech transfer QA** **2.1 Product Transfer:** + QA Lead for below quality activities during Product transfer including, + Technology Transfer plan + Test Method Transfer/Analytical Method + Validation/Verification + Process Validation/verification Program. + Stability program during Shelf-Life of the product Microbiological validation studies + 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. + 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. + Responsible for ensuring that all the quality activities during technology and/or analytical method transfer are timely completed meeting the Quality Standards. + Complete technical data package and add specific report, summarizing current product robustness from sending unit and complete the package during technology transfer. + To Assist in quality and compliance of the product and process during identification of the commercial manufacturing site and all the technology and/or analytical method transfers and improvements. + To provide support for preparation of CMC document for the regional supported products during technology transfer. + Provide Quality Technical Leadership for process and regulatory deficiency issues. Liaison between sites QA, commercial affiliates, MS&T and other groups as necessary **2.2 Technical Support:** + Provide rapid and expert support to facilitate issue resolution for investigations and compliance issues at TPMs. + QA coordinator for Management of Change. CR initiator for compliance remediation activities and possible task assignee. + Supporting in product and process quality and compliance throughout the maturity stage of the life cycle of EPD commercialized products. + Ensure that new or changed specifications comply with regulatory and quality expectations. + Participate to the process of creation, approval and continuous improvement of the regulatory documentation related to EPD products; Ensure compliance of that documentation which is required to support the product manufacturing but could be not directly implemented in the submission package. + Liaison with other Regional PT&TS QA as well as other QA functions. + Coordinate Stability Risk Assessment activities for assigned projects. + Serve as quality technical support of regional EPD Quality organization during process and regulatory deficiency issues, risk assessment target cost initiatives and other continuous improvement initiatives. + Serve as quality technical support of regional EPD Quality organization for alternative supply studies for API’s and other critical process changes. **Apply Now :** + Follow 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 An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com