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Posted:8 hours ago| Platform: Linkedin logo

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On-site

Job Type

Full Time

Job Description

  • 15+ years of experience in Warehouse operations, with at least 7 years in a supervisory role in injectable manufacturing.
  • Strong understanding of regulatory requirements, cGMP, and industry best practices.
  • Proven leadership abilities and excellent communication skills.
  • Ability to work cross-functionally and resolve quality-related challenges efficiently.
  • Prior experience in successfully facing regulatory audits, including USFDA, EU-GMP and ANVISA is mandatory.



Material Receipt and Storage:

  • Ensure all materials are stored and handled according to cGMP and regulatory requirements.
  • Ensure regular recording of temperature, RH and DP in the designated logbooks to maintain optimal storage conditions for materials.

Warehouse Maintenance and Cleanliness:

  • Ensure the cleanliness and organization of the warehouse.

Material Handling and Dispensing:

  • Dispense raw materials and issue packing materials following FIFO (First In, First Out) system.
  • Ensure proper handling, storage, and distribution of materials in line with company procedures and safety standards.

Compliance and Documentation

  • Ensure compliance with cGMP standards and regulatory requirements in all warehouse operations.
  • Maintain up-to-date inward registers for raw materials, packing materials, consumables, and trial materials.
  • Follow good documentation practices (GDP) and ensure timely completion of SOP training, log books, and stock card entries.
  • Participate in audits and compliance assessments, ensuring the warehouse meets all regulatory and internal standards.
  • Ensure that warehouse processes, documentation, and operations are audit-ready at all times.

Safety and Hygiene

  • Ensure adherence to safety protocols and hygiene standards, including personal hygiene and gowning procedures as per SOPs.
  • Ensure the warehouse team follows safety instructions during work operations.

Quality Risk Management:

  • Handle rejected materials and coordinate the disposition of such materials.
  • Participate in Quality Management System (QMS) activities such as deviations, CAPA (Corrective and Preventive Actions), and change control.
  • Conduct regular quality risk assessments and ensure that warehouse processes comply with quality standards.

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