Specialist - Biotech (QA Operations)
Julphar
Date: 15 hours ago
City: Ras al-Khaimah
Contract type: Full time
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
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.
- 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.
- 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.
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