Urwah Admin

Julphar

Julphar is one of the leading pharmaceutical companies in the UAE and the Gulf region, dedicated to improving the quality of life by providing a wide range of medicines, vaccines, and consumer healthcare products. The company emphasizes innovation and quality in its manufacturing processes, ensuring that it meets the highest standards of safety and efficacy. Julphar is committed to delivering real value and solutions for various health conditions, from common ailments to chronic diseases.

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  Job Purpose
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 To oversee the end-to-end procurement, lifecycle management, and validation of GxP-regulated equipment and software. This role ensures total compliance with cGMP, 21 CFR Part 11, and QMS standards while maintaining a safe, environmentally compliant operational environment.
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  Responsibilities
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   Supporting the team for procuring equipment &amp; preparing the related documents like User request specification (URS), CAPEX approval, technical comparison sheet and procuring the equipment/software.
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   Equipment life cycle management along with corresponding teams.
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   QMS (Ample logic) activities related to Equipment/software/system /CSV (new and legacy equipment) before &amp; after the installation and Maintenance.
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   Supporting the team for preparing and updating the SOPs related to Equipment/software spare parts and column system as cGMP.
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   Guiding the team for procuring (requesting &amp; Approval) and maintaining columns with the respecting documents. And maintaining the columns stock &amp; Equipment spares in SAP.
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   Leading the team in Computer system validation (CSV) for new procuring GxP equipment/software and establishing the same CSV for legacy equipment. Computer system validation as per 21 CFR part 11 for legacy GxP equipment/software implementation by phase wise.
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   Supporting the team for arranging and maintaining the Archive room activities.
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   Preform any other work assigned by Manager and support colleagues whenever necessary.
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   Execute daily operations in compliance with EMS and HSE standards, using appropriate PPE and safe practices.
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   Identify, reduce, and prevent environmental impacts and operational risks.
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   Contribute to EHS activities, audits, and continual improvement initiatives.
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  Education &amp; Experience
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   Bachelor&rsquo;s degree in pharmacy/ chemistry/chemical engineer or related Sciences. With minimum 5 years&rsquo; experience in the Product Development/Research and Development from a Pharmaceutical field.
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   Should have handled similar role for a better fitment of this role.
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   Proven experience of the chemical composition, structure, and properties of substances and of the chemical processes and transformations that they undergo. This includes uses of chemicals and their interactions, danger signs, production techniques, and disposal methods.
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   Advance Knowledge of statistics, and their applications.
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   Strong Knowledge in international guidelines such as ICH, USP, EP, BP and WHO. Scientific approaches in method development and method validation. Different instrumentation and instruments trouble shooting. And analytical trouble shooting.
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 </ul>
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Sr. Research Analyst 1

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 To lead and oversee the Quality Assurance Compliance team in ensuring that all operations comply with
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  cGMP, GDP, ISO, and regulatory requirements
 </strong>
 . The QA Compliance Process lead is responsible for supervising quality system activities, managing audits and inspections, and driving continuous improvement initiatives to maintain a high standard of quality compliance across the organization.
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  Quality System Oversight
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   Lead and manage daily QA compliance operations, ensuring adherence to company and regulatory requirements.
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   Oversee the implementation, maintenance, and continuous improvement of the Quality Management System (QMS).
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   Supervise review and closure of deviations, market complaints, CAPAs.
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   Ensure quality system data is analyzed, trended, and reported through compliance KPIs and management reviews.
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  Audits and Inspections
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   Plan, coordinate, and lead internal audits and self-inspections according to the annual audit schedule.
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   Prepare the organization for regulatory inspections and customer audits; coordinate responses and follow-up on findings.
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   Review and approve audit reports and ensure timely and effective implementation of corrective and preventive actions (CAPAs).
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  Documentation and Records Management
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   Supervise the control, review, and approval of SOPs, quality manuals, and other controlled documents.
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   Ensure compliance with Good Documentation Practices (GDP) and manage document lifecycle from issuance to archival.
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   Support departments in documentation compliance and timely updates of controlled procedures.
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  Training and Team Leadership
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   Lead, coach, and develop the QA Compliance team, ensuring adequate training and competency development.
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   Conduct and facilitate GMP and compliance-related training sessions for staff across departments.
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   Foster a quality culture that emphasizes compliance, accountability, and continuous improvement.
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  Continuous Improvement and Risk Management
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   Lead or participate in quality improvement and risk management projects.
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   Identify compliance gaps and propose systematic solutions.
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   Ensure proper implementation of data integrity principles (ALCOA+) across all quality systems.
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 </ul>
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  Environmental, Health And Safety Responsibilities
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   Follow the company&rsquo;s Environmental Management System (ISO 14001:2015) and HSE policies in daily work.
  </li>
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   Actively minimize environmental impacts, maintain a safe workplace, and handle tasks responsibly (e.g. proper disposal of waste, safe use of equipment).
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   Report hazards, non-conformities, or environmental issues to supervisors and support continual improvement initiatives.
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   Leadership and Accountability
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   Quality and Compliance Focus
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   Continuous Improvement Mindset
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   Collaboration and Cross-Functional Coordination
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   Integrity and Professionalism
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   Bachelor&rsquo;s or Master&rsquo;s Degree in Pharmacy, Chemistry, Biology, Biotechnology, or a related or equivalent field
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   Minimum 5-10 years of experience in Quality Assurance / Compliance within the pharmaceutical or biotechnology industry, including at least 2&ndash;3 years in a supervisory or team leadership role.
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   Comprehensive understanding of GMP, GDP, and ISO 9001 and ISO 14001 requirements
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   Strong familiarity with regulatory guidelines (FDA, WHO, EU).
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   Experience in audits, CAPA, risk management, and QMS systems.
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   Excellent leadership and team management skills.
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   Strong communication, coordination, and decision-making abilities.
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   Analytical thinking and problem-solving skills.
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   Proficiency in MS Office and electronic QMS platforms.
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 </ul>
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Team Lead -Deviation & CAPA

<div></div><div><div><div><div><div><p>Detailed Job Description:</p>
<p>
Main Responsibilities:</p>
<h3 class="jobSectionHeader"><b>
1. Technical &amp; Quality Leadership</b></h3>
<ul><li>Manage all technical- related functions and departments within the plants as per the SFDA Guidelines.</li>
<li>Final approval of suppliers of semi-finished/ Raw Material and packaging materials, technical agreements for outsourcing activities and all changes of building, utilities, production lines and products variation</li>
<li>Oversee the implementation, monitoring, and continuous improvement of the Quality Management System (QMS).</li>
<li>Review and approve critical quality and technical documentation (e.g., Site Master File, Quality Manual, Validation Master Plan).</li>
<li>Approve process validation, equipment qualification, and change control activities.</li>
<li>Authorize investigations related to deviations, out-of-specifications (OOS), and product complaints.</li>
<li>Manage product recall processes and ensure proper documentation and corrective actions.</li>
<li>Final approval of the organogram and the job description.</li>
</ul><h3 class="jobSectionHeader"><b>2. Regulatory &amp; Compliance</b></h3>
<ul><li>Ensure full adherence to cGMP, GLP, GDP, and SFDA regulatory requirements.</li>
<li>Responsible for representing the plant during the SFDA inspection along with the QA.</li>
<li>Approve responses and CAPA plans related to internal, external, and regulatory audits.</li>
<li>Oversee management of controlled and narcotic substances in compliance with Saudi regulations.</li>
<li>Ensure accuracy and completeness of all technical documents submitted for product registration and renewal.</li>
<li>In Case of Recall, Responsible to manage the investigation the Recall Process in coordination with the QA department.</li>
</ul><h3 class="jobSectionHeader"><b>3. Operational &amp; Strategic Management</b></h3>
<ul><li>Approve supplier/vendor qualifications for raw materials, packaging materials.</li>
<li>Ensure proper execution of technology transfer and product lifecycle management activities.</li>
<li>Conduct internal audits and management reviews to assess QMS performance and drive continual improvement.</li>
</ul><h3 class="jobSectionHeader"><b>4. Leadership &amp; Staff Development</b></h3>
<ul><li>Define roles, responsibilities, and performance expectations for technical staff.</li>
<li>Identify competency gaps and implement training and development programs.</li>
<li>Evaluate employee performance and promote a culture of accountability, quality, and safety.</li>
<li>Foster effective communication and collaboration across technical and quality functions.</li>
</ul><h3 class="jobSectionHeader"><b>5. Additional Duties:</b></h3>
<ul><li>Prepare and present technical and operational performance reports for senior management.</li>
<li>Support external audits, inspections, and regulatory visits.</li>
Perform any other job-related duties as assigned in line with business needs.<br>
<li>
</li>
</ul><h5 class="jobSectionHeader"><b>6. Environmental, Health and Safety Responsibilities:</b></h5>
<ul><li>Follow the company&rsquo;s Environmental Management System (ISO 14001:2015) and HSE policies in daily work.</li>
<li>Follow and ensure compliance with Saudi Safety Guidelines like, NCOSHA, SASO, OSH, NEBOSH,</li>
<li>Actively minimize environmental impacts, maintain a safe workplace, and handle tasks responsibly (e.g. proper disposal of waste, safe use of equipment).</li>
<li>Report hazards, non-conformities, or environmental issues to supervisors and support continual improvement initial.</li></ul><br>
<p></p>
<p>
Core Competency:</p>
<ul>
<li>In terms of competency, you are highly result-oriented with an intense sense of accountability &amp; ownership.</li>
<li>High compliance adherence, having strong diligence, initiative-taking, and flexibility.</li>
<li>Excellent communication, interpersonal, and collaboration skills.</li>
<li>Having demonstrated skills in leadership and people management</li>
<li>Motivated, organized, focused &amp; overall compliance.</li>
<li>Must be able to manage tasks, plan workload effectively, prioritize, and easily adapt to changing situations.</li>
<li>Identify, reduce, and prevent environmental impacts and operational risks.</li>
<li>Contribute to EHS activities, audits, and continual improvement initiatives.</li></ul><br>
<p></p>
<p>
Qualification/Functional Knowledge:</p>
<ul>
<li>Education: Bachelor&rsquo;s or Doctorate degree in Pharmaceutical Sciences / Pharmacy (B.Pharm or PharmD) &ndash; mandatory as per SFDA regulations</li>
<li>Experience: Minimum 10 years in pharmaceutical manufacturing, quality assurance, or related technical fields, including leadership experience in a cGMP-regulated environment, with minimum 5 years of Similar Role</li>
<li>Comprehensive understanding of GMP, GDP, ISO 9001 and ISO 14001 requirements.</li>
<li>Strong familiarity with regulatory guidelines (e.g. SFDA, FDA, WHO, EU).</li>
<li>Experience in audits, CAPA, risk management, and QMS systems.</li>
<li>Excellent leadership and team management skills.</li>
<li>Analytical thinking and problem-solving skills.</li>
<li>Proficiency in MS Office and electronic QMS platforms</li></ul></div></div></div></div></div><p></p>

Manager-Technical

Join Julphar and explore 3   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Julphar

About Company

Sr. Research Analyst 1

Team Lead -Deviation & CAPA

Manager-Technical