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Specialist QA (QC oversight)
Julphar
Sharjah, UAEAED 6,000-16,000/moToday
UAEScience ResearchFull Time
Job Description
At Julphar, we are on a journey of culture transformation & our mission is to provide a better quality of life for the entire family by delivering best in class solutions and real value with compassion and professionalism.Our core values: Respect, Collaboration, innovation, Integrity and Compassion – combined with a focus on diversity, inclusion, and equal opportunities – are key drivers in our aim to make a positive impact on the lives of the patients we serve, enable talents, create a healthy work environment, and accomplish our goals through world‑class research and the compassion and commitment of our employees.Roles and ResponsibilitiesMonitoring and ensuring current Good Laboratory Practices (GLP) and Good Documentation Practices (GDP) followed by laboratory personnel during a routine operation to ensure adherence to procedure.Investigating the “Out of specifications” reported for Finished products, Stability samples, Raw Materials and Packaging Materials.Investigating “Out of Trend” reported for analysis results as per the approved procedures.Implementing Quality Assurance systems effectively including handling of QMS activities in R&D.Actively participating in laboratory investigations and incidents ensuring GLP/GDP compliance.Handling of excursions observed with Environmental monitoring, water system monitoring.Handling of temperature / RH excursions in the stability chambers, refrigerators, incubators.Review of Technical documents prior to QA approval (SOPs, Stability protocols/reports, URS, Qualification protocols, Qualification reports, Out of Calibration reports, Calibration delay reports, Instruments under maintenance reports).Review of Audit trail checklist as per approved procedures.Ensure all instruments are qualified & calibrated and complying to CSV requirements.Collate and review data to be used in reports, investigations, key performance indicators (KPIs) and other quality‑indicating metrics.Qualification / Functional KnowledgeA bachelor's degree in Pharmaceutical Sciences, Analytical Chemistry or related field of study from an accredited institution. (Master's degree in the above fields of study preferred)Strong knowledge and experience with analytical laboratory activities in areas such as active pharmaceutical ingredients (API), drug products, analytical development, Quality Control (QC), Good Laboratory Practices (GLP)/Good Manufacturing Practices (GMP).A minimum of 3–5 years of relevant work experience in a pharmaceutical manufacturing company within the Quality function.Strong documentation and technical writing skills, and ability to apply relevant scientific principles and practices.Proficient computer skills and experience with software applications such as Microsoft Office and Quality applications and software programs.Well‑versed knowledge of Quality Assurance principles.Preferred Additional KnowledgeKnowledge of Microbiology Laboratory activities.Knowledge of Manufacturing processes (Sterile & Non‑Sterile dosage forms).Experience using statistical software.We value people from different backgrounds. Could this be your story? Apply today or visit www.Julphar.net to read more about us and the journey of Julphar.#J-18808-Ljbffr
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