Karima Afandi Email and Phone Number
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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.
Idibe - Umh
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Research And Development InternIdibe - Umh Feb 2023 - PresentSpanyolTFM / 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). -
Graduate StudentEmotion Master Sep 2021 - PresentPiemonte, ItaliaERASMUS+ 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/ -
Study Abroad AdvisorKobi Education Nov 2022 - PresentJakarta, Jakarta Raya, IndonesiaConsulting, 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. -
Skincare Technical TranslatorTia'M Global (Fireworks Company) Feb 2022 - Sep 2022Seoul, Korea SelatanTranslating 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.
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Gmp Audit Management OfficerDexa Medica (Member Of Dexa Group) Oct 2016 - Aug 2021Palembang Dan Sekitarnya, Sumatera Selatan, IndonesiaResponsible 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. -
Production StaffFerron Par Pharmaceuticals (Member Of Dexa Group) Feb 2016 - Mar 2016Bekasi, Jawa BaratAssisting 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. -
Production StaffZenith Pharmaceuticals Ltd. Jul 2015 - Aug 2015SemarangIndustrial 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. -
General AssistantPersatuan Haji Pogung Medical Clinic Oct 2012 - Oct 2014Provinsi Yogyakarta , Indonesia
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Research StudentUniversity Of Cyberjaya Jul 2014 - Aug 2014Cyberjaya, Selangor, MalaysiaPart 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 -
Student ResearcherUniversitas Gadjah Mada (Ugm) Feb 2014 - Aug 2014Yogyakarta, Daerah Istimewa Yogyakarta, IndonesiaDevelopment 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. -
Student Laboratory AssistantUniversitas Gadjah Mada (Ugm) Feb 2014 - Jun 2014Department 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. -
Student Laboratory AssistantUniversitas Gadjah Mada (Ugm) Feb 2013 - Jun 2013Department 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. -
Microbiology Laboratory AssistantUniversitas Gadjah Mada (Ugm) Feb 2012 - Jun 2012Department 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
Karima Afandi Education Details
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Fragrance Formulation For Industrial And Scientific Applications. -
Pharmaceutical Sciences -
3.95/4.00 | Valedictorian -
3.86/4.00
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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