Specialist - Biotech (QA Operations)

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.

Detailed Job Description

• Responsible for QA oversight functions in Biotech plants.
• To ensure cGMP compliance in area (Monitoring good documentation practices, correctness of batch documents, logbooks, labels etc./ gowning attire / cleanliness / adherence to SOP’s, manufacturing & packaging instructions etc.)
• To perform in-process quality check activities according to SOP in production/ packaging departments in complying with cGMP principles and captures test results in batch records.
• To verify line clearance / line release activities as per SOP.
• To review batch manufacturing records and batch packaging records for batch release.
• To prepare Annual Product Quality Review of Biotech plants.
• To perform Change & CAPA assessments related to products / plants of Biotech.
• To support site QA lead performing product quality related investigations and risk assessments.
• Review of all technical department SOP’s & documents for adequacy of procedure contents.
• To perform site inspections regularly and monitor the self-inspections & GMP inspections CAPA compliance.
• To comply with the end-to-end activities of Biotech plants.
• Maintain safe and healthy work environment by following standards, procedures and complying with regulations.
• Any other responsibilities assigned by Site QA Lead / QA Manager/ Quality Director.
  
  

Qualification/Functional Knowledge

• Bachelor/ Master’s degree in Science.
• Minimum 3 to 4 years in Quality operation in Biotech manufacturing.
• Good knowledge and command on cGMP.
• Good computer knowledge and knowledge of QMS system “Agile, Trackwise, Amplelogic”
• To be proficient in English.
• Quality and Business decision maker.
• Risk assessment knowledge.
  
  

Core Competency

• To be good in Process compliance.
• Strong understanding and practice of 'cost consciousness'.
• Good Command in English.
• High on Accountability & Ownership.
• Good in team building, Time & Task Management.
• To be disciplined, Open for new learnings at the workplace.
  
  

We value people from different backgrounds. Could this be your story? Apply today or visit www.Julphar.net to read more about us and the journey of Julphar.