Specialist QA (QC oversight)

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.

Roles and Responsibilities

• Monitoring 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.
• Investigation of “Out of Trend” reported for analysis results as per the approved procedures.
• Implementing Quality Assurance systems effectively including handling of QMS activities in in the 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 report, Calibration delay reports, Instruments under maintenance reports)
• Review of Audit trail checklist as per approved procedures
• Ensure all the 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 Knowledge

  
  
  • A 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.
  • Must possess strong documentation and technical writing skills, and be able to apply relevant scientific principles and practices.
  • Must be proficient in computer skills and software applications such as Microsoft Office tools and Quality applications and software programs
  • Well versed knowledge of Quality Assurance principles required.
  • Knowledge on the following will be added advantage
  • Knowledge of Microbiology Laboratory activities
  • Knowledge on Manufacturing process (Sterile & Non-Sterile dosage forms)
  • Experience of 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