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Analyst, Quality Compliance
3 meses atrás
Founded by Samih Darwazah over 40 years ago in Jordan, Hikma's purpose is to provide affordable, quality medicines to the people who are competent. Based on very solid foundations, we continue to innovate daily and find practical solutions to transform the lives of the millions of people we serve.
At the end of the 1980s, we extended ours beyond the Middle East and acquired land in Portugal for the construction of a sterile factory for injectable pharmaceutical products. This was an important turning point for the company, and our first step into a new region. Today, in Portugal, we have more than 900 employees and 3 factories for the production of injectable medicines.
Hikma, intends to recruit an Analyst, Quality Compliance (m/f) to integrate Quality Control Department, on-site work.
Main Responsibilities:
Initiate stability studies in all facilities: requesting the stability batches, preparing the samples, and placing them on the stability chambers Sampling of stability batches for Quality Control, Analytical Research and Micro departments Introduction stability data on software LIMs and treat stability data from LIMs and Novatek Performance of Loss of Weight stability analysis for all the batches filled in bag form. Review the result. Receiving and login of stability samples Monitoring and evaluate data from the stability chambers, laboratory areas and QC fridges and freezer. Perform trend reports for each semester Reviewing and updating stability protocols in use Coordinate the shipment of samples to be tested in external contract laboratories Responsible for QC and QA orders for all needed materials, reagents, standards, etc. Management of Hikma 4 reagents warehouse (expiry dates and stocks) Verification and maintenance of samples, chambers and other logbooks Ensure documentation practices according to the company quality requirements Writes / Review SOPs upon request (including all SOPs for secondary packaging material for QA) Elaboration of memos, events, and deviation reports Transportation of stability and commercial samples between facilities Performs job tasks in strict adherence to Standard Operating Procedures (SOPs), company Good Manufacturing Practices (cGMPs) and Food and Drug Administration (FDA) requirementsProfile:
Degree in Chemistry or related science English medium level Computer knowledge on common office applications Good interpersonal / communication skills Good organization skillsWe offer:
Direct contract with Hikma Salary appropriate to the functions performed Life insurance Health insurance Annual Performance Bonus High career prospectsIf you think this is a good opportunity for your professional career, join us and contribute to Better Health, within everyone's reach, every day
