Specialist - QA Sterile

Title: 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.

Job Summary

The QA Specialist is responsible for ensuring adherence to cGMP principles and maintaining effective quality control throughout the in-process production and packaging activities for biotech and sterile products. The role supports the implementation of Julphar’s procedures and policies, ensuring smooth functioning of QA in-process quality activities. This position also involves participation in audits, deviation investigations, and documentation to ensure compliance with regulatory and internal standards.

Key Responsibilities / Key Result Areas

• Adhere to and enforce cGMP principles in all in-process quality checks and activities.
• Investigate deviations and support corrective and preventive actions.
• Participate in media fills and ensure process compliance during production and packaging.
• Review processes and procedures with a quality mindset to ensure compliance.
• Participate in internal and external regulatory audits.
• Perform in-process quality checks according to SOPs in production and packaging departments and record results in batch records.
• Inspect incoming materials to confirm specifications and return unacceptable materials.
• Review and maintain in-process control documents and logbooks; document inspection results accurately.
• Input quality data into the SAP system and assist in preparing Annual Product Quality Review (APQR) reports.
• Ensure calibration and proper functioning of in-process check equipment.
• Conduct line clearance checks before production or packaging activities.
• Verify all materials required for manufacturing steps are available and compliant.
• Maintain accurate records of all QA activities and perform necessary tests in the plant.
• Plan and assign daily job duties to meet quality and operational goals.
• Maintain a safe and healthy work environment by following procedures and regulatory requirements.
  
  

• Results-oriented with a strong sense of accountability and ownership.
• High compliance adherence, attention to detail, proactive, and flexible.
• Strong communication, interpersonal, and collaboration skills.
• Quick learner, able to grasp new concepts and implement them effectively.
• Organized, focused, and motivated to achieve compliance and business goals.
• Effective task management, workload planning, and adaptability to changing situations.
• Ability to translate new learnings into practical workplace applications.
  
  

• Bachelor’s or Master’s degree in Pharmacy.
• Knowledge of EU Annex-1 and cGMP requirements.
• Minimum 3–5 years of experience in quality operations within sterile manufacturing.
• Proficient in computer applications and QMS systems such as Agile, Trackwise, and Ampelogic.
• Strong command of English (written and spoken).
• Competent in making quality and business decisions.
• Familiarity with risk assessment and quality compliance practices.