Labeling Operations Specialist

15 hours ago


Hyderabad, Telangana, India beBeeLabeling Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
Labeling Operations Specialist

We are seeking a Labeling Operations Specialist to drive and execute labeling activities for clinical trial supplies. The successful candidate will ensure the fulfillment of supply chain requirements, resulting in no stockouts, missed milestones, and supply interruptions impacting patients due to label quality or availability.

Key Responsibilities:
  • Generate and coordinate labels for IMP, medication list, randomization list, and randomization schedules, ensuring agreed landmarks, quality, and costs are met.
  • Ensure label compliance with study design, pack design, pack material, analytical specifications of the IMP, country-specific regulatory requirements, and standards of compliance.
  • Maintain a validated repository of country-specific regulatory requirements and translations of phrases in country-specific languages.
  • Lead and co-lead system enhancement initiatives as appropriate.
  • Be a qualified GMP line unit checker for labels and drive a culture of quality within the team.
  • Lead investigations in case of quality events, deviations, or non-RFT cases when required.
  • Communicate challenges to internal and external customers and bring solutions to mitigate any risks.
  • Lead as a subject matter expert and functional guide on label process during internal and external inspections.
Requirements:
  • 5 years of practical experience in the chemical/pharmaceutical industry or 3 years of experience in a field of expertise.
  • Good knowledge of the Drug Development and clinical supply process.
  • Basic project management, good organization, and planning skills.
  • Knowledge of relevant regulations (e.g., GMP, HSE) and standards.
  • Demonstrates problem-solving and idea generation skills.
  • Good presentation skills, fundamental leadership skills, very good communication, negotiation, and interpersonal skills.
  • Ability to work in interdisciplinary teams.

 

About Us

We aim to reimagine medicine to improve and extend people's lives. Our vision is to become the most valued and trusted medicines company in the world. We believe that our associates drive us each day to reach our ambitions.



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