Specialist - QA Sterile

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.

Role & Responsibiities

• Perform line clearance and release activities according to established Standard Operating Procedures (SOPs).
• Conduct in-process quality checks on products during manufacturing and packaging, ensuring results are within defined limits and timelines.
• Accurately document all test results and observations in batch-related documentation to ensure complete traceability and compliance.
• Ensure the correct materials and components are used in production and packaging, following specifications outlined in BMR (Batch Manufacturing record), BPR (Batch packaging record), MPI (Master Packaging Instructions), MIV (Material Issue Voucher), or Dispensing Sheets.
• Maintain strict adherence to current Good Manufacturing Practices (cGMP) within the assigned area, ensuring proper documentation, verification of entries, and record integrity across batch records, logbooks, and labelling systems.
• Verify proper gowning attire, cleanliness, and adherence to SOPS, manufacturing instructions, and packaging instructions.
• Ensure environmental conditions (temperature, humidity, and differential pressure) meet the requirements for the product and the work area.
• Verify that in-process check equipment is properly calibrated and functions as intended.
• Assist in preparing the Annual Product Quality Review (APQR) for products as per established
  
  

• Participate in both and external audit programs.
• Participate in audit readiness programs.
• Handle tasks related to the Quality Management System (QMS) deviations and market complaints at the worksite.
• Conduct investigations into quality-related issues like deviations or complaints.
• Manage Corrective Action and Preventive Action (CAPA) processes within the Ampelogic system.
• Manage Change Control Report (CCR) processes within the Ampelogic system.
• SOPs, BMRs and BPRs review.
• Perform Site gap assessment and site GEMBA.
• Sample adherences follow up.
• Participate in quality risk assessment preparation (facility and processes).
• Ensure that all activities in related plants are performed in compliance with the requirements of the sites.
• Perform other duties as ass ned the QA rations Team Leader/QA Manager.
  
  

• Bachelor oh Pharmacy
• 4 years of experience in Quality assurance
• Knowledge on computer system MS office
• Good knowledge of SOPS and batch records review.
• Advance knowledge with cGMP principles and production process.