Aseptic Operations Specialist

2 days ago

Sápes, East Macedonia and Thrace, Greece beBeeQuality Full time
Quality Assurance Specialist

Pharmathen is seeking a highly skilled Quality Assurance Specialist to join our Quality Operations team. This role is responsible for ensuring compliance with Good Manufacturing Practices (GMP) and ISO standards, as well as preparing and authorizing quality management documents.

Key Responsibilities:

  • Ensure the compliance of Quality Management Systems Requirements according to FDA regulations and International Standard ISO 9001 and 14001
  • Participate in preparation and authorship of Quality Management departments SOPs, TDRs, and other controlled documents of the Quality System
  • Provide real-time quality oversight during aseptic manufacturing, including formulation, filling, visual inspection, and packaging of sterile injectable products
  • Review and approve batch manufacturing records, logbooks, and controlled documentation related to sterile operations
  • Act as the primary QA contact for customer-related quality matters, including deviations, documentation requests, and quality-related queries

Requirements:

  • Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, Chemical Engineering, or a related field
  • Minimum 5-7 years' experience in Quality Management or relevant department

Job-Specific Skills:

  • Excellent communication skills in English language (writing & speaking)
  • Computer literacy
  • Ability to prioritize tasks and meet deadlines
  • Exceptional communication skills, strong project management skills

Benefits:

  • Opportunity to leverage and develop your business knowledge and skills in a high-caliber, team-oriented, and dynamic atmosphere

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