Pharma QC Specialist: GMP/GLP Analytics

Julphar

Abu Dhabi

On-site

AED 70,000 - 90,000

Full time

2 days ago
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Job summary

Julphar in the United Arab Emirates seeks an experienced Quality Control Analyst to perform chemical and physical analyses of raw materials, intermediates, and stability samples in line with SOPs and GMP/GLP requirements.

The role involves operating HPLC, GC, UV‑Vis spectrophotometers, and dissolution testing, maintaining accurate records, and ensuring data integrity using SAP and GDP practices. Collaboration with QA, Production, and R&D is essential.

Qualifications

  • Bachelor's degree in Pharmacy, Chemistry, or a related Science discipline.
  • Minimum 3–6 years of relevant experience in pharmaceutical Quality Control.
  • Strong technical knowledge and hands‑on experience in HPLC, GC, UV-Vis spectrophotometry, dissolution testing, and other pharmaceutical analytical techniques.
  • Sound knowledge of GMP, GLP, SOPs, and applicable regulatory guidelines, including USP, EP, and BP.
  • Experience in analytical method validation, method transfer, and assay analysis.
  • Strong understanding of data integrity principles, ALCOA+ compliance, and Good Documentation Practices.
  • Working knowledge of Quality Management System activities, including CAPA, AMS, Change Controls, and audit compliance.
  • Proficiency in SAP, AmpleLogic, and computer software applications.
  • Ability to maintain accurate laboratory records, analytical results, and test reports.
  • Strong analytical, troubleshooting, and problem‑solving skills.
  • Excellent attention to detail and commitment to quality and regulatory compliance.
  • Effective written and verbal communication skills.
  • Ability to work collaboratively with cross‑functional teams, including QA, Production, and R&D.
  • Strong organizational and time‑management skills with the ability to manage multiple tasks and priorities.
  • Highly disciplined, accountable, and responsible, with a strong sense of ownership.
  • Self‑motivated, adaptable, and willing to learn and implement new technical knowledge.
  • Strong commitment to laboratory safety, environmental protection, and continuous improvement.

Responsibilities

  • Perform chemical and physical analysis of raw materials, semi-finished products, and stability samples in accordance with approved analytical methods, specifications, and SOPs.
  • Operate QC laboratory equipment, including HPLC, GC, UV-Vis spectrophotometers, dissolution apparatus, and other analytical instruments as applicable.
  • Ensure all analytical testing activities are performed accurately and within established timelines, in compliance with GMP, GLP, and regulatory requirements.
  • Ensure tested products meet established quality specifications and applicable pharmacopoeial standards, including USP, EP, and BP.
  • Maintain accurate and complete records of analytical results, laboratory observations, and testing activities in accordance with GDP.
  • Enter analytical results and relevant laboratory data into SAP accurately and on time.
  • Ensure compliance with data integrity principles and ALCOA+ requirements across all laboratory activities.
  • Support analytical method validation and method transfer activities as required.
  • Handle and support QMS activities, including CAPA, AMS, and Change Controls through AmpleLogic system.
  • Participate in internal and external audits, provide required laboratory documentation, and support timely closure of audit observations.
  • Strictly follow approved SOPs, laboratory safety procedures, and company quality policies.
  • Maintain laboratory cleanliness, hygienic working conditions, and proper handling of laboratory materials and equipment.
  • Assist in troubleshooting analytical issues and resolving day-to-day laboratory operational challenges.
  • Ensure daily laboratory operations comply with EMS and EHS standards.
  • Use appropriate PPE and follow safe laboratory practices to minimize hazards and risks.
  • Identify, report, and support the prevention of environmental impacts and safety risks associated with laboratory activities.
  • Participate in EHS activities, audits, and continual improvement initiatives.
  • Coordinate effectively with QA, Production, R&D, and other departments to support quality and operational requirements.
  • Support QC supervisors and designated personnel in assigned laboratory and departmental activities.
  • Contribute to continuous improvement initiatives aimed at enhancing laboratory efficiency, analytical accuracy, quality compliance, and operational performance.

Skills

HPLC
GC
UV-Vis spectrophotometry
Dissolution testing
GMP/GLP compliance
Data integrity ALCOA+
CAPA/AMS/Change Controls
SAP experience
AmpleLogic

Education

Bachelor's degree in Pharmacy or Chemistry

Tools

SAP
AmpleLogic

Job description

Julphar in the United Arab Emirates seeks an experienced Quality Control Analyst to perform chemical and physical analyses of raw materials, intermediates, and stability samples in line with SOPs and GMP/GLP requirements.

The role involves operating HPLC, GC, UV‑Vis spectrophotometers, and dissolution testing, maintaining accurate records, and ensuring data integrity using SAP and GDP practices. Collaboration with QA, Production, and R&D is essential.

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