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 - Technical Transfer and Support & Development Quality
Assurance Manager - METAP
This position works out of our Egypt, Cairo office in the Established
Pharmaceutical division (EPD).
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 Technical Transfer and Support & Development Quality Assurance Manager,
you'll be responsible for Product Transfer, Technical Support, Product
Development and Clinical QA for Middle East, Africa, Turkey and Pakistan.
What You 'll Do
Product Transfer and Support QA
* QA Lead for below quality activities during Product Transfer and ASQ including,
* Change Control / Stability and Change Impact Assessment
* 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
* 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.
* Supporting the lifecycle management strategy and supporting its operational execution as supporting the work-stream team or equivalent cross-functional team. Managing product and process quality and compliance throughout the maturity stage of the life cycle of EPD commercialized 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.
* 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.
* 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.
* Conduct/assist in due-diligence audits for new API suppliers to provide a rapid and accurate usage decision on proposed suppliers
* 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
Development and Clinical QA
* QA representative for innovation and development projects at regional Third-Party Development Center and Karachi Technical Center
* Responsible as sending QA for developed product activities from development center to manufacturing site
* To undertake clinical center 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.
* 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 Chemistry, Pharmacy, Medical Science.
* 5 + years of supervisorial experience in the pharmaceutical (Quality, Production, R &D etc.) or related fields.
* GMP/GLP/GCP background related to medicinal products, medical device, food supplement Biotechnological, Biosimilars and Biologics
* 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.