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:
Career development with an international company where you can grow the career you dream of.
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 - QUALITY ASSURANCE MANAGER - MEAP
This position works out of our DAFZA , Dubai office in the Established Pharmaceutical division.
Established Pharmaceuticals 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 Quality Assurance Manager, you’ll be responsible for Product Transfer, Technical Support and Clinical QA for Middle East, Africa and Pakistan. Additionally supporting Turkey based on business requirements.
WHAT YOU’LL DO
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.
Complete technical data package and add specific report, summarizing current product robustness from sending unit and complete the package during technology transfer.
Involve in support the quality aspects of the Product Portfolio Expansion Initiatives and Geographic Expansion initiatives and other Non-Centrally Supported Products.
Liaison between sites QA, commercial affiliates, MS& T and other groups as necessary.
Responsible for creation of post-transfer Quality documentation.
Liaison with other Regional PT& TS OA as well as other QA functions.
Supporting the lifecycle management strategy and supporting its operational execution as supporting the work-stream team or equivalent cross-functional team.
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.
Contribute to the final decision making on the usage of new Third Party Manufacturers (TPMs) within the EPD division. Provide Quality Leadership in the Regional EPD team structure.
QA Lead for all Product and Method Transfers and new source qualification of Active Pharmaceutical Ingredients (APIs). Responsible for Quality Risk Management (ICH Q9).
Act as Regional NPI Coordinator for Geo-Expansion, L&A and different project.
Conduct/assist in due-diligence audits for new API suppliers to provide a rapid and accurate usage decision on proposed suppliers
Implementing and maintaining policies, processes, procedures and plans that define the elements necessary to meet the Product Transfer QA objectives, as well as regulatory and business requirements.
Responsible for ensuring that all the quality activities during technology and/or analytical method transfer are timely completed meeting the Quality Standards.
Establishing and communicating the PT QA standards and objectives in alignment to the EPD Quality Manual and synchronize PT QA activities with such standards.
TECHNICAL SUPPORT
Provide expert support to quality related aspects and facilitate issue resolution for key investigation and compliance issues
Supporting the lifecycle management strategy and supporting its operational execution as member of the work-stream team or equivalent cross-functional team.
Supporting in product and process quality and compliance throughout the maturity stage of the life cycle of EPD commercialized products.
Managing product and process quality and compliance throughout the maturity stage of the life cycle of EPD commercialized products,
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.
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
Ensure that new or changed specifications comply with regulatory and quality expectations.
Specification setting, review and approval as member of the CMC workstreams or during Technology Transfers (concurrent product modernization/remediation).
In this role TS QA is responsible to:
Review the proposed specifications for appropriate control of drug product.
quality attributes and assesses justifications/supportive data adequacy to support the new specifications or change of specifications.
Assesses the specifications against current regulatory standards, expectations and requirements.
Maintains consistency of specifications across product family if appropriate.
Approve the specifications
Ensure that new or changed specifications comply with regulatory and quality expectations
NEW PRODUCT INTRODUCTION (GEO-EXPANSION, L&A DEALS, EXBR, CODE, KTC (KARACHI TECHNICAL CENTER) AND I&D RELATED ACTIVITIES)
QA representative in the New Product Introduction (NPI) process, process/product development and Innovation and development (I&D) projects.
Provide support as QA representative in the Product Workstream.
Core team members in HIVE and/or QA Community of Practice (CoP)
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 continues improvement initiatives.
CLINICAL
Support the strategy and execution for PV/GCP/GLP QA goals.
To undertake audit activity with the purpose to qualify vendors, as requested by the business, for Good Clinical Practice (GCP).
To undertake audit activity with the purpose to qualify vendors, as requested by the business, for Good Clinical Practice (GCP).
To manage the audit activity through SolTRAQs and upload the audit related documentation in reasonable time to allow the GCP QA Approved Vendor List publication from Global GCP within the related quarter.
Manages, builds and strives to continuously improve the regional GCP/GLP quality assurance (QA) program.
Actively participates in and supports GCP/GLP and resolution of findings. Collects and analyses KPIs, and analyses trends.
Promotes continuous education on GCP/GLP regulations for self and other Abbott staff by attending external training sessions.
To conduct the qualification audit and document the outcome of the audit activity as “satisfactory”, “unsatisfactory” or “contact QA”.
Manages the regional EPD QA PV/GCP/GLP audit program, including development and maintenance of the risk-based audit plan, publish the annual audit schedule, assignment of appropriately qualified Lead-/Co-auditors.
Vendors qualification requested or used by Region: Responsible as Regional GCP/ PV QA for qualification, re-qualification and oversight.
Manages the documentation of the GCP/GLP QA related processes and procedures.
REQUIRED QUALIFICATIONS
Bachelor's degree in Pharmacy/ Medical Science.
5 + years of supervisorial experience in similar markets in the pharmaceutical or related fields.
GCP background, related to clinical trial and pharmacovigilance.
Good communication and report writing skill 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.
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.
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