Specialist - Product Life Cycle

Julphar; Ras Al Khaimah; On-site; USD 60,000 - 80,000; Full time

Job summary

A leading pharmaceutical company is seeking a validation specialist to oversee quality assurance processes in sterile facilities. The role involves ensuring compliance with regulatory bodies, conducting validation studies, and collaborating with cross-functional teams. Ideal candidates should possess a Bachelor’s degree in Pharmacy/Science with relevant experience in validation and regulatory audits. Join this innovative organization committed to enhancing quality of life through exceptional healthcare solutions.

Qualifications

• Minimum 3-5 years experience in validation and quality systems.
• Experience with SFDA, WHO, EU & USFDA audits.
• Proficient in English and knowledge of cGMP.

Responsibilities

• Responsible for process and cleaning validation documents.
• Conduct investigation of incidents related to validation.
• Monitor CAPA effectiveness regarding validation.

Skills

Problem-solving

Communication

Accountability

Collaboration

Education

Bachelor of Pharmacy/Science

Tools

Agile

Veeva-Valut

Track wise

Amplelogic

Job description

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.

Key Responsibilities

• Responsible for the process and cleaning validation documents and oversight the execution activities for the Sterile Facilities (Liquid Injectable, Lyophilized and Sterile powder filling)
• Responsible for the Process Validation of API biological drug substance.
• Familiar with the filter Validation Requirements in the sterile Area.
• Responsible for the designing of Aseptic process simulation study. Preparation of Protocols and reports.
• Responsible for the Visual inspection Qualification process.
• Responsible for the Shipping Validation for the cold Chain products.
• Investigation of the incidents, OOS, returns goods and all manufacturing related non-conformances with respect to validation.
• Review of change controls, CAPAs and deviations related to qualification and validation. Act as Quality general in EQMS to complete the actions associated with qualification and validation activities.
• Monitoring the CAPA effectiveness related to validation.
  
  

Core Competency

• In terms of competency you are highly result oriented with strong sense of accountability & ownership.
• Ability to prioritize, multi-task and work effectively under pressure to meet deadlines.
• Good communication, interpersonal and collaboration skills.
• Highly disciplined and must be organized, self-motivated to learn new learnings and implement them at workplace
• Technical expertise required for the Qualification and Validation in Sterile and Biotech plants.
• Good implantation skills and easily adapt to changing situations.
• Must be able to work in a cross-functional environment interacting with other internal and external departments
• Must be able to communicate technical, scientific, and regulatory information, both written and verbally.
  
  

Qualification/Functional Knowledge

• Bachelor of pharmacy/Science with minimum work experience of 3-5 years.
• Well experience on SFDA, WHO, EU & USFDA audit exposure.
• Good Computer knowledge and knowledge of QMS system “Agile, Veeva-Valut, Track wise, Amplelogic.”
• Proficient in English.
• Demonstrated solid experience in problem-solving and team management.
• Good Knowledge and command of cGMP
• Risk Assessment knowledge.
  
  

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