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.

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.

• 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.

We value people from different backgrounds.