Job Title

Third Party Manufacturer and Technical Transfer QA Associate/Sr.Associate (TPM-TT QA)/OUTSOUCED OPPORTUNITY

About Abbott

Abbott 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 Abbott

At 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 Opportunity

As Third-Party Manufacturer and Technical Transfer QA Associate /Sr. Associate, you’ll be responsible for TPM Management and Product Transfer and Technical Support for Egypt and Saudi.

This position works out of our Egypt affiliate 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-Supplier QA Manager, you’ll be responsible for:

Providing QA support for assigned TPM’s and/or Suppliers to ensure that safe, efficacious, and quality product can be supplied to Abbott METAP-CIS region 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 & Supplier activities while driving continuous improvement for TPMs and Suppliers.Responsible for Monitoring quality performance for assigned TPMs / suppliers and ensure requirements per Quality Technical Agreements are adhered / followed by assigned TPMs and suppliersLeading Quality Technical Agreements approval and renewalPrimary 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 regional Approved Supplier Listing.Responsible for communication with Global TPM/Supplier QA regarding Global TPM Products that are supplied for Egypt and Saudi.Responsible for supporting Global and Regional Quality Compliance and improvement initiatives.Support new contract manufacturing site approvals within METAP-CIS region 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 and supplier sitesQA lead for co-ordination with TPMs & Supplier 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 regional and affiliate goals.

As Product Technology Transfer QA

Act 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 ProgramFirst 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 issuesInvolve 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) and other groups as necessary.Act as Regional NPI Coordinator for Geo-Expansion, L&A (License and Acquisition) and different project.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 disciplineMinimum 5 years of experience in the pharmaceutical manufacturing field (Quality, production, technical support,etc)Comprehensive understanding of a wide range of Pharmaceutical Manufacturing and Testing OperationsKnowledge of international and local quality system and compliance legislations and standardsGMP/GLP/GCP background related to medicinal products, medical device, food supplement Biotechnological, Biosimilars and BiologicsGood communication and report writing skills in English and Arabic.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: 20 %

Preferred Qualifications

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.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 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.

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