Team Leader - 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

Job Summary And Responsibilities

• Processing: Dispense raw materials, formulation, material preparation, filtration, filling, inspection, labeling, and shipment in strict adherence to GMP principles.
• Process Documentation: Prepare, review, and approve process-related documentation such as Batch Manufacturing Records (BMR), Standard Operating Procedures (SOPs), and logbooks.
• Machine Operations: Assemble machine parts in the cartridge filling line and manage cartridge filling operations during the media fill and batch production processes within Class-B areas.
• Material Management: Monitor and check production materials such as raw materials, PPM, and SPM, and plan accordingly for production requirements.
• Cross-Functional Teamwork: Collaborate with cross-functional teams to ensure critical project tasks are completed effectively.
• SOP Training and Revision: Prepare, revise, and provide training on all required SOPs within the department.
• Batch Record Review: Review processed batch records prior to product release to ensure quality standards are met.
• Process Validation: Oversee process validation, optimization, and scale-up activities to ensure quality and efficiency.
• Cleaning Schedules: Coordinate area cleaning schedules and ensure proper disinfectants are used for cleaning.
• Cleanroom Maintenance: Maintain the cleanliness and compliance of Class-A & Class-B cleanroom areas.
• Aseptic Training: Provide proper training for aseptic operators, ensuring adherence to cleanroom behaviors.
• Maintenance Support: Initiate and follow up on breakdown maintenance work orders and preventive maintenance procedures.
• Employee Training: Provide ongoing job role training for employees to ensure operational excellence.
• Support CIP & SIP: Assist with CIP (Clean-in-Place) and SIP (Sterilization-in-Place) programs as required.
• Problem Resolution: Investigate and troubleshoot issues, recommending solutions or improvements to enhance operational performance.
• EDMS and eQMS Tools: Handle EDMS (Electronic Document Management System) and eQMS (Electronic Quality Management System) tools like Change Control, Deviations, Exception Management, CAPA, etc.
• SOP Development: Write, review, and propose new or updated SOPs to improve the Quality Management System (QMS) and related processes.
• Assistance in Unit Operations: Assist in other unit operations and activities as required or instructed by the Manager or Department Head.
  
  

• Strong communication skills with the ability to collaborate effectively within a team and across functional areas.
• Quick learner with the ability to adapt to new processes and systems efficiently.
• Accountable, committed, and results-oriented with a focus on meeting deadlines.
• Proficient in reading and understanding SOPs and BMRs to ensure compliance.
• Bachelor's degree in Pharmacy or Pharmaceutical Chemistry.
• Advanced knowledge of cGMP (current Good Manufacturing Practices) principles and production processes.