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Specialist - Quality Control
2 weeks ago
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 with the compassion and commitment of our employees. Job Description As a member of the Microbiology Quality Control team, you will be responsible for conducting a range of microbiological tests to ensure compliance with regulatory and internal quality standards. Your key responsibilities will include: Microbiological Testing & Analysis - Perform testing of sterile samples including Sterility, LBPC (Limulus-Based Pyrogen Test), and BET (Bacterial Endotoxin Test) with proper documentation. - Conduct testing of non-sterile samples, such as Microbial Limit Test (MLT) and Bioburden, along with accurate record-keeping. - Perform microbiology assay testing and document results in compliance with GMP. - Carry out microbiology culture testing including maintenance, sub-culturing, Growth Promotion Testing (GPT), and microbial identification. Water & Environmental Testing - Perform water testing, release analysis, and related documentation. - Conduct environmental monitoring in classified areas across Julphar production plants and microbiology labs, ensuring accurate and timely documentation. Lab Support Activities - Execute various microbiology lab support activities including equipment monitoring, cleaning validations, and media preparation. - Monitor equipment and area temperatures using Vaisala/SIRIUS systems. - Ensure real-time documentation and compliance for all assigned tasks. - Handle sample and result entries, reservation creation, and notification processes in SAP. Compliance & Documentation - Adhere strictly to Good Laboratory Practices (GLP), Data Integrity, and Good Documentation Practices (GDP). - Prepare and review Standard Operating Procedures (SOPs) and support microbiology-related qualification/validation documentation. - Participate in internal and external audits and promptly report any deviations, OOS (Out of Specification), OOL (Out of Limit), or excursions. - Manage documentation and deviation handling through eQMS (Amplelogic system). Safety & Best Practices - Follow all safety protocols and ensure a clean and compliant laboratory environment. - Ensure full compliance with company policies, GMP, and regulatory guidelines. Core Competencies - Strong sense of accountability and ownership - Highly disciplined, motivated, and well-organized - Excellent process compliance and implementation skills - Effective time and task management - Proficient English communication skills (verbal and written) Qualifications & Functional Knowledge - Bachelor's or Master's Degree in Microbiology or other Biological Sciences - 4–6 years of relevant experience in a pharmaceutical microbiology lab (preferably in sterile and non-sterile product testing) - Proficient in computer applications including MS Word, Excel, and PowerPoint - Familiarity with SAP, eQMS (Amplelogic), and temperature monitoring systems like Vaisala/SIRIUS is a plus We value people from different backgrounds. Could this be your story? Apply today or visitwww.Julphar.netto read more about us and the journey of Julphar #J-18808-Ljbffr
