Quality Assurance Specialist

4 weeks ago


Ambler Pennsylvania, United States INSUD PHARMA, S.L.U. Full time
Job Description

At INSUD PHARMA, S.L.U., we are seeking a highly skilled Quality Assurance Technician to join our team. This role is responsible for ensuring the quality of our pharmaceutical products and processes.

Key Responsibilities:
  • Deviations Management: Investigate and report deviations, collaborate with relevant departments to establish corrective actions, and evaluate their effectiveness.
  • Corrective Actions: Follow up on corrective actions and assess their impact on quality.
  • Investigations: Collaborate with departments to investigate out-of-specification results and laboratory events.
  • Risk Analysis: Prepare and evaluate risk analyses associated with commercial products.
  • Standard Operating Procedures: Develop and maintain standard operating procedures.
  • KPIs: Prepare key performance indicators for the Quality Assurance area.
  • Internal and External Audits: Participate in internal audits and support external audits.
  • Product Quality Review: Support the Product Quality Review activity.
Requirements:
  • Education: University degree in Pharmacy, Chemistry, Biology, or related field.
  • Experience: 1-2 years of experience in the pharmaceutical industry, with knowledge of aseptic practices a plus.
  • Knowledge: Familiarity with GMP normative EU/US/PICS.
  • Language: English level B1/B2.
  • Skills: Good communication skills, proactivity, team working, problem-solving, and organizational skills.


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