Senior Specialist Quality Control

RK, AE, United Arab Emirates

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.


Job Summary/Main Purpose




The Senior Specialist in the Quality Control division is responsible for ensuring that all products meet the required quality standards and regulatory requirements. This role involves supervising and following up on chemical and physical analysis of finished products, raw materials, and packaging materials. The Senior Specialist will oversee analysts in the QC department, ensuring that all analyses are performed correctly and in compliance with GLP, GMP, and safety procedures. Additionally, the role includes training newly joined staff, managing data entry and verification on SAP, troubleshooting and solving operational problems, and conducting investigations for lab incidents, OOS, OOT results, and deviations. The Senior Specialist will also be involved in external and internal audits, review and approve protocols and reports, and handle quality management system actions.




Key Responsibilities




To adhere with the cGMP principles and to maintain them in an effective manner. Responsible to follow up chemical and physical analysis of finished products/ Raw &Packaging Materials Supervising and follow up analysts, instrumental and physical lab in QC. Supervising analysts results of FP/RM/PM. Supervising and follow up analyst instrumental and physical lab in QC department Responsible for the operation of various QC equipment (depending on the section) To ensure and follow GLP, GMP, safety procedures and maintain hygienic conditions in lab. Training newly joined staff Entering and checking data of analyst on SAP Assist in trouble shooting and solving problems that may come up in the day-to-day operation of the department. Ensure Final Products adhere to all specifications and regulations. Create HPLC & GC analytical methods from approved STM/Pharmacopoeia for all analysts before starting analysis Processing and approval for all HPLC &GC analytical data for all analysts, review and check all the Audit trial for all the instruments. To train the QC personnel on all the applicable procedures, specifications, testing methods and qualify analysts to perform various QC analysis. To ensure the analysis are performed correctly as per applicable procedures To perform investigation for the lab incidents, OOS, OOT results, deviations and take appropriate corrective and preventive actions. To lock the results in SAP, to create notifications & reservations for maintaining enough stock of chemicals & consumables. To involve and support in external and internal audits and to close the audit observations on time. Review and approve protocols and reports such as method validation, method transfer, process validation and stability. To handle and close the Quality management system actions like Deviations, OOS, CAPAs, AMS and Change controls using Amplelogic system. To follow and ensure data integrity and good documentation practices are implemented in the QC labs. Apart from the above, the works assigned by the Head of the department/designee.

Core Competency




In terms of Competency, you are highly oriented with a strong sense of accountability & ownership, Excellent communication, interpersonal and presentation skills. Technical Competencies: In-depth knowledge of the industry's standards and regulations guidelines excellent knowledge of reporting procedures and record keeping, must have experience in handling Regulatory Authorities audits and questions and accordingly set up the action plan Having an Analytical mind with ability to think diversely and understand the big picture, Methodical and diligent with outstanding planning abilities, an analytical mind able to "see" the complexities of procedures and regulations Strong Manpower handling skills and having effective team communication and motivational skills. Capable of suggesting ideas in a structured manner and having good Command on English language. High on communication and collaboration, having an ability to manage multiple stakeholders at a time. Strong eye for details, having expertise to understand, review and implement the compliance inputs from Quality point of view. In-depth knowledge of the industry's standards and regulations guidelines, excellent knowledge of reporting procedures and record keeping. Must be able to manage tasks and priorities and easily adapt to changing situations. Ability to create cross functional relations and manage conflicts. Problem Solving and high agility on taking right scientific decisions.


Qualifications, Key Experiences / Functional Knowledge Requirements:





Bachelor's degree in chemistry or pharmacy Proven experience in quality control and/or quality assurance roles, preferably in a leadership capacity. Strong knowledge of regulatory requirements and quality standards relevant to the industry. Excellent analytical, problem-solving, and decision-making skills. Strong leadership and team management capabilities. Minimum 5 years of experience in QC/QA department. Must be experienced in managing complex and sensitive operational challenges.





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

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Job Detail

  • Job Id
    JD1818584
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    RK, AE, United Arab Emirates
  • Education
    Not mentioned