Sr. Specialist

Julphar

Ras Al Khaimah

On-site

AED 201,000 - 335,000

Full time

31 hours ago
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Job summary

Julphar in Ras Al Khaimah seeks a Senior Specialist/Team Leader for the OSD plant to lead production/packaging, ensure GMP compliance, and drive cross-functional coordination. The role requires overseeing CAPA, deviations, and batch documentation to maintain quality and regulatory readiness.

The incumbent will supervise operators and technicians, train staff on SOPs and safety, and partner with QA, R&D, engineering, and regulatory teams to optimize processes and ensure efficient production while

Qualifications

  • Education: B. Pharm / M. Pharm / M.Sc. in Pharmaceuticals, Chemistry, or related field.
  • Experience: 6-10 years in OSD pharmaceutical manufacturing, with at least 2-3 years in a supervisory or managerial role.
  • Knowledge & Skills: GMP, regulatory compliance, and safety guidelines; experience with OSD equipment like granulators, tablet presses, coating machines, and blenders; leadership and strong communication and documentation skills.

Responsibilities

  • Oversee and manage OSD production/packaging processes; ensure schedules, output, and quality.
  • Ensure compliance with cGMP, WHO, FDA/foreign regulatory standards; maintain in-process quality checks and document deviations.
  • Supervise packaging staff, conduct SOP/GMP training, and monitor performance for continuous improvement.
  • Maintain equipment calibration and maintenance; identify process improvement opportunities and collaborate with engineering/maintenance.
  • Ensure safety compliance and waste handling per regulatory norms; conduct risk assessments and preventive actions.
  • Prepare plant for regulatory inspections and customer audits; manage batch records and validation protocols.

Job description

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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

The Sr. Specialist/Team Leader in the OSD plant is responsible for overseeing and managing production/Packaging activities, ensuring compliance with GMP, regulatory guidelines, and safety protocols. The role involves coordinating with cross-functional teams to achieve production targets, maintaining product quality, and optimizing operational efficiency.

Key Responsibilities
1. Production/Packaging Management
  • Supervise and manage the OSD production/Packaging process, including granulation, compression, coating, and packaging.
  • Ensure adherence to production/packaging schedules and optimize output while maintaining product quality.
  • Coordinate with the supply chain, planning, and warehouse teams to ensure smooth material availability.
  • Troubleshoot production/packaging-related issues and implement corrective and preventive actions (CAPA).
2. Compliance & Quality Assurance
  • Ensure all operations comply with cGMP, WHO, SFDA, USFDA, MHRA, and other regulatory standards.
  • Work closely with the Quality Assurance (QA) team to ensure in-process quality checks.
  • Handle deviations, change controls, and investigations related to production/packaging activities.
  • Maintain proper documentation in accordance with regulatory and company standards.
3. Team Management & Training
  • Supervise and mentor production/packaging staff, including operators, technicians, and junior executives.
  • Conduct training programs on SOPs, GMP guidelines, and safety procedures.
  • Monitor employee performance and provide feedback for continuous improvement.
4. Equipment & Process Optimization
  • Ensure the proper functioning, calibration, and maintenance of production/packaging equipment.
  • Identify opportunities for process improvements and cost reduction while maintaining quality.
  • Collaborate with the engineering and maintenance teams for timely resolution of equipment issues.
5. Safety & Compliance
  • Ensure adherence to workplace safety guidelines and implement safety measures.
  • Conduct risk assessments and take necessary preventive actions to minimize hazards.
  • Ensure proper handling and disposal of waste as per environmental and regulatory norms.
6. Regulatory & Audit Readiness
  • Prepare the plant for regulatory inspections and customer audits.
  • Ensure timely completion of all documentation, including batch manufacturing records (BMR), standard operating procedures (SOPs), and validation protocols.
  • Address audit findings and implement corrective measures.
Qualifications & Experience
  • Education: B. Pharm / M. Pharm / M.Sc. in Pharmaceuticals, Chemistry, or related field.
  • Experience: 6-10 years of experience in OSD pharmaceutical manufacturing, with at least 2-3 years in a supervisory or managerial role.
  • Knowledge & Skills:
  • Strong understanding of GMP, regulatory compliance, and safety guidelines.
  • Experience in operating and troubleshooting OSD equipment like granulators, tablet presses, coating machines, and blenders.
  • Leadership and team management skills.
  • Excellent problem-solving and decision-making abilities.
  • Strong communication and documentation skills.
Work Environment & Additional Information
  • The role requires working in a controlled manufacturing environment.
  • May involve working in shifts, depending on production needs.
  • Requires collaboration with QA, R&D, engineering, and regulatory teams.

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