Karima Afandi

Karima Afandi Email and Phone Number

Pharmacist | Quality Management System | Quality Auditor | Cosmetics, Pharmaceutical & Dermatology @ IDiBE - UMH
Karima Afandi's Location
Elche, Valencian Community, Spain, Spain
Karima Afandi's Contact Details

Karima Afandi work email

Karima Afandi personal email

n/a
About Karima Afandi

Passionate about the quality and regulatory world of pharmaceutical, medical device, skincare and cosmetics with an ongoing pursuit of learning through an International Master in Cosmetics and Dermatological Sciences program in Europe.Experienced Pharmaceutical Quality Auditor with a successful track record of conducting audits and supplier quality review for more than 50 companies, including overseas audits for various types of pharmaceutical products and suppliers (including sterile, non-sterile, raw materials, manufacturing, packaging material, and pharmaceutical distributors). Strong knowledge of GMP and different regulations, quality control procedures, risk management, and internal audit processes.Skilled in coordinating and assessing the gap, creating corrective and preventive actions (CAPA), implementing and assessing new regulations for the company, and continuously seeking to improve processes together with related departments. Considered a fast learner, growth-oriented, adaptable, proactive, and able to work effectively both as a team player and independently.

Karima Afandi's Current Company Details
IDiBE - UMH

Idibe - Umh

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Pharmacist | Quality Management System | Quality Auditor | Cosmetics, Pharmaceutical & Dermatology
Karima Afandi Work Experience Details
  • Idibe - Umh
    Research And Development Intern
    Idibe - Umh Feb 2023 - Present
    Spanyol
    TFM / Final Master Thesis Research in IDiBE. It is the Institute of Research, Development, and Innovation in Healthcare Biotechnology in Elche (Instituto de Investigación, Desarrollo e Innovación en Biotecnología Sanitaria de Elche).Working mainly in Investigating in vitro dermo-cosmetics activities such as UV protection, anti-hyperlipidemic, anti-glycation, and anti-aging properties on seven different extracts of indigenous plant that showed psychoactive activity using different skin cell lines (Keratinocyte, Melanocyte, Fibroblast).
  • Emotion Master
    Graduate Student
    Emotion Master Sep 2021 - Present
    Piemonte, Italia
    ERASMUS+ Scholarship Awardee of Erasmus Mundus Joint Master Degree (EMJMD): EMOTION Master - European Master in Translational Cosmetic and Dermatological Sciences EMOTION Master is a two-year Master's degree program aimed at training the next generation of Research and Development leaders in the dermatological and dermacosmetic field. The program is taught in English and involves study at multiple partner universities (University of Eastern Piedmont, Italy | University of Miguel Hernandez, Spain | University of Namur, Belgium | University of Berlin, Germany), followed by a personalized thesis project in either industry or academia. https://www.emotion-master.eu/
  • Kobi Education
    Study Abroad Advisor
    Kobi Education Nov 2022 - Present
    Jakarta, Jakarta Raya, Indonesia
    Consulting, guiding, and advising prospective students on their study abroad journey based on their current profile. Creating a support ecosystem that helps students to build portfolios to prepare them for studying abroad including advising the cultural and academic differences they may encounter. Providing ongoing support and resources during the preparation of studying abroad.
  • Tia'M Global (Fireworks Company)
    Skincare Technical Translator
    Tia'M Global (Fireworks Company) Feb 2022 - Sep 2022
    Seoul, Korea Selatan
    Translating skincare technical documents (dossier, marketing materials). Ensuring that the translations accurately convey technical information and maintain the same level of quality and consistency as the original documents.
  • Dexa Medica (Member Of Dexa Group)
    Gmp Audit Management Officer
    Dexa Medica (Member Of Dexa Group) Oct 2016 - Aug 2021
    Palembang Dan Sekitarnya, Sumatera Selatan, Indonesia
    Responsible to manage all the activities related to second and third-party audit GMP and QMS related to PT. Dexa Medica such as : 1. Managing supplier qualification and audit for:-Materials (Active Pharmaceutical Ingredient, Excipient - sterile & non-sterile)-Packaging Materials (Primary, Secondary, Tertiary Materials)-Imported Finished product-Toll Manufacturer-Distributor (Finished Product and Materials)-Contract Laboratory and Contractual Service, Making risk assessment, plan, audit, documentation, report, CAPA, and CAPA evaluation as part of new supplier qualification and existing supplier evaluation. To ensure that the supplier complies with GMP and internal requirements. 2. Coordination with the related department (purchasing, QC, etc.) to evaluate the supplier.3. Managing third-party audits from the government and participating in audits from other certification bodies. In charge of maintaining company certifications.4. Evaluating current and or future regulations/system with the site’s implementation. Coordinating and communicating the regulation with all departments. Advising CAPA for gap and or better compliance. 5. Following up on the CAPA and checking the implementation effectiveness.6. Involved in internal and external audit programs representing Dexa Medica.7. Yearly audit and certification budgeting and reporting. 8. Conducting and preparing the material for Basic GMP Training.
  • Ferron Par Pharmaceuticals (Member Of Dexa Group)
    Production Staff
    Ferron Par Pharmaceuticals (Member Of Dexa Group) Feb 2016 - Mar 2016
    Bekasi, Jawa Barat
    Assisting experienced production pharmacists with various tasks, such as: preparing training materials for the new production line (Active Pharmaceutical Ingredients Sterile 5 Production Line), following several investigations related to the new line, and following the aseptic validation process (media fill). Learning about different aspects of pharmaceutical production, including line clearance, product and cleaning validation, qualification and calibration, production processes, in process control, environmental control, material and supply chain management.
  • Zenith Pharmaceuticals Ltd.
    Production Staff
    Zenith Pharmaceuticals Ltd. Jul 2015 - Aug 2015
    Semarang
    Industrial Internship related to ISPE's program. Working mainly related to Process Validation and Process Improvement in Production Area supervised by Production Manager. -Investigating, analyzing, reporting, and presenting the possible problem-solving related to the current primary packaging process issue in the production plant.-Participating in continuous improvement initiatives and lean manufacturing implementation to enhance the efficiency and effectiveness of production processes.-Assisting with the validation of production processes to ensure that they meet regulatory and quality requirements-Participating in creating process validation protocol for syrup products.
  • Persatuan Haji Pogung Medical Clinic
    General Assistant
    Persatuan Haji Pogung Medical Clinic Oct 2012 - Oct 2014
    Provinsi Yogyakarta , Indonesia
  • University Of Cyberjaya
    Research Student
    University Of Cyberjaya Jul 2014 - Aug 2014
    Cyberjaya, Selangor, Malaysia
    Part of the IPSF (International Pharmaceutical Student Federation) Exchange Program. Mainly joining the research conducted by the students in CUCMS, Cyberjaya, Malaysia, and participating in the lectures and inter-cultural program.-Participating in ongoing research projects under the guidance of a mentor or supervisor.-Participating in seminars, workshops, and other training opportunities to enhance research skills and knowledge.-Gained insight into Malaysian Pharmacy and Health System through active participation in lectures, discussions, and field trips.-Representing the host institution in a professional and positive manner while interacting with other researchers and institutions
  • Universitas Gadjah Mada (Ugm)
    Student Researcher
    Universitas Gadjah Mada (Ugm) Feb 2014 - Aug 2014
    Yogyakarta, Daerah Istimewa Yogyakarta, Indonesia
    Development of Herbal Syrup and Self Nano-emulsion Drug Delivery System Syrup from Gynura Procumbens.Responsible for developing an analytical method of syrup and nano-syrup formulation using HPLC, TLC, and Spectrophotometry to assure the quality of herbal extract and dosage form.
  • Universitas Gadjah Mada (Ugm)
    Student Laboratory Assistant
    Universitas Gadjah Mada (Ugm) Feb 2014 - Jun 2014
    Department Of Pharmaceutical Technology And Social Pharmacy, Ugm, Faculty Of Pharmacy
    -Assisting and helping freshman pharmacy students with laboratory work in the Pharmaceutics laboratory, including; holding the lab pre-test and post-test, and conducting experiments in the lab.-Analyzing, and grading the reports submitted by the students and submitting the grade to the supervisor.-Participating in laboratory safety training and following established safety procedures to ensure a safe and secure working environment.
  • Universitas Gadjah Mada (Ugm)
    Student Laboratory Assistant
    Universitas Gadjah Mada (Ugm) Feb 2013 - Jun 2013
    Department Of Biology Pharmacy, Faculty Of Pharmacy, Ugm
    -Assisting and helping freshman pharmacy students with laboratory work in the Microbiology laboratory, including; holding the lab pre-test and post-test, and conducting experiments in the lab.-Analyzing, and grading the reports submitted by the students and submitting the grade to the supervisor.-Participating in laboratory safety training and following established safety procedures to ensure a safe and secure working environment.
  • Universitas Gadjah Mada (Ugm)
    Microbiology Laboratory Assistant
    Universitas Gadjah Mada (Ugm) Feb 2012 - Jun 2012
    Department Of Biology Pharmacy, Faculty Of Pharmacy, Ugm
    -Assisting and helping freshman pharmacy students with laboratory work in the Microbiology laboratory, including; holding the lab pre-test and post-test, and conducting experiments in the lab.-Analyzing, and grading the reports submitted by the students and submitting the grade to the supervisor.-Participating in laboratory safety training and following established safety procedures to ensure a safe and secure working environment.

Karima Afandi Skills

Internal Audit External Audit Certified Quality Auditor Quality Auditing Good Manufacturing Practice Iso 9001 Iso 14001 Ohsas 18001 Supplier Quality Management Supplier Qualification Quality Management System Iso Standards

Karima Afandi Education Details

Frequently Asked Questions about Karima Afandi

What company does Karima Afandi work for?

Karima Afandi works for Idibe - Umh

What is Karima Afandi's role at the current company?

Karima Afandi's current role is Pharmacist | Quality Management System | Quality Auditor | Cosmetics, Pharmaceutical & Dermatology.

What is Karima Afandi's email address?

Karima Afandi's email address is ka****@****ica.com

What schools did Karima Afandi attend?

Karima Afandi attended Università Degli Studi Di Firenze, Universidad Miguel Hernández De Elche, Università Degli Studi Del Piemonte Orientale, Universitas Gadjah Mada (Ugm), Universitas Gadjah Mada (Ugm).

What are some of Karima Afandi's interests?

Karima Afandi has interest in Science And Technology, Environment, Education, Health.

What skills is Karima Afandi known for?

Karima Afandi has skills like Internal Audit, External Audit, Certified Quality Auditor, Quality Auditing, Good Manufacturing Practice, Iso 9001, Iso 14001, Ohsas 18001, Supplier Quality Management, Supplier Qualification, Quality Management System, Iso Standards.

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