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 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.
- 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 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.
- 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 Knowledge
- Knowledge 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 to read more about us and the journey of Julphar.