pharmaceutical industry, manufacturing, quality, TQM, R&D, regulatory

Lydia Hany Tharwat Azer R&D/ Regulatory Affairs Associate Manager/ TQM

Location: 6 Ahmed Mahmoud St. – Heliopolis

Telephone: 012********

Email: *****.******@*****.***

Professional profile

Pharmacist; R&D Senior Specialist with 3 years of experience within pharmaceutical industry. I’m having Experience in regulatory and quality processes.

TQM Diploma Holder from the AUC

Proven ability to Implement and maintain GDP, GMP& GLP

Detail-oriented worker with documentation experience

Project management skills. Good planning and organizational skills and ability to manage a large workload under pressure and to cope with tight deadlines.

Experience in Microsoft Project, Microsoft Office (Word, Excel, PowerPoint). Punctuality and time-keeping, Able to take on responsibility, Good organization, with attention to detail, and Quick learner, keen to learn and improve skills. Analytical skills – time management skills.

Career summary

April 2020 – Present The Hair Addict

Research & Development / Regulatory Affairs Associate Manager

Key responsibilities

Support the implementation of the company Product Strategy

Manage the entire development process of a new product based on the company's Products Planning, as well as improvements to existing collections.

Allocate funds for every project and keep track of all the costs related to the creation of any new product.

Solidify the culture and role of product innovation within the company's strategy and develop new-to-the world and superior products in all related products in our portfolio.

Proactively manage proper project management for all projects, secure Product Specification Requirements with target price, target dates before the start of any new development.

Create a Product Development Schedule for every new product or collection.

Direct and manage all activities to research, develop, sample, test and launch new products in the swiftest and most efficient manner possible. Work with other teams to deliver new products to the market within the defined schedule and budget.

Identify project risks and potential product issues and recommend solutions.

Organize and conduct Product Reviews to present prototypes/samples to management

Stay informed on what is happening in the research and development field at large in order to make sure our company is up-to-date.

Be in contact with Health Authorities in relation to obtaining market authorization.

Responsible for Artwork update

September 2017 – April 2020 Eva Pharma, Haram Premises

Senior R&D DC Specialist

Outline

Responsible for the issuance of pilot and production batch record. R&D SOPs. NODCAR files submission and following up and answering MOH queries in timely manner until granting the final approvals and sharing them with all concerned stakeholders. Filling in all MOH forms and templates required for submission. Submission of the importation plans / approvals together with all the related documents to the concerned departments at MOH (Registration department – licensing department – importation department).

Key responsibilities

Reviewing, analyzing and approving reports and registration files.

Participates in the development of R&D department policies, and procedures and ensures implementation of all relevant procedural/legislative requirements

Follows up regularly with authorities, internal departments and agents on related submissions and files to ensure meeting deadlines

Compilation of registration and re-registration files

Dealing with NODCAR for analysis and conformity, Responsible for all activities related to NODCAR (from preparation to submission)

Preparation of the regulatory documents required for submission of Licenses and approvals of Products, ensuring that the documents are valid and complete at the time of submission (registration licenses, variations approvals, etc.)

Preparing documentation and compiling registration submissions to regulatory authorities in order to register the company’s new products and maintain existing registrations.

Responsible for the issuance of pilot and production batch records related to the R&D department

Support the product release process by reviewing and approving requests for product release

Key achievements/projects

Application of One Drive system (more secured) for the R&D team for controlling documents

Application of Own Cloud system for the R&D team for controlling documents

January 2017 – August 2017 Spice Kingdom, Obour city

Q.A Specialist

Outline

Record and document results and compare to expected results. Detect failures so that defects may be discovered and corrected. Generate historical analysis of test results. Document irregularities and issues. Ensure compliance with general best practices. Responsible for the performance of certificates of analyses.

July 2016 – September 2016 Janssen Pharmaceuticals, Nasr city (scientific office)

Medical Representative

Outline

Organizing appointments and meetings with community- and hospital-based healthcare staff, demonstrating or presenting products to healthcare staff including doctors, nurses and pharmacists, meeting both the business and scientific needs of healthcare professionals, maintaining detailed records, managing budgets, writing reports and other documents.

January 2015 – March 2015 AstraZeneca Pharmaceuticals, Location

Medical Representative

Outline

Demonstrating or presenting products to healthcare staff including doctors, nurses and pharmacists, meeting both the business and scientific needs of healthcare professionals.

Education & qualifications

Total Quality Management System, Excellent – AUC (American University in Cairo) – 2018

Bachelor Degree in Pharmaceutical Sciences, GPA 3.28 – OCTOBER UNIVERSITY FOR MODERN SCIENCES AND ARTS– 2016

Scientific science High school degree, 93 % – Saint Fatima El-Hegaz Language School – 2016

Languages

English: Fluent

French: Medium

References available on request

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