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(GMP) QA Associate (m/f)

(GMP) QA Associate (m/f)

Posted 28 January by PAION UK Ltd
Easy Apply Ended

PAION is a publicly listed specialty pharmaceutical company developing and aiming to commercialize innovative drugs for out-patient and hospital-based sedation, anesthesia and critical care services. PAION’s lead compound is remimazolam, an intravenous, ultra-short-acting and controllable benzodiazepine sedative/anesthetic drug candidate for which PAION has completed the clinical development for use in procedural sedation in the U.S. Outside the U.S., PAION is currently focused on the development of remimazolam for general anesthesia. Development of remimazolam for intensive care unit (ICU) sedation is also part of the longer-term life-cycle plan for remimazolam. PAION's vision is to become an acknowledged "PAIONeer" in sedation and anesthesia. PAION is headquartered in Aachen (Germany) with an additional site in Cambridge (United Kingdom).

For our team in Cambridge we are currently searching an

(GMP) QA Associate (m/f)

Your tasks & responsibilities:

  • QA support to all other departments within PAION
  • Assist in the maintenance and management of PAION's QMS
  • Writing/review/approval of internal Quality documents/records (deviations, CAPAs, Change control, SOPs, complaints)
  • Conducting Self-Inspections
  • Conducting supplier/vendor assessment and approval and supporting GxP audits
  • Support QA team in maintain and managing PAION's Quality and Technical agreements including writing, review and filling
  • QA review and approval of external documentation and records (deviations, Change Controls, specifications, master batch records QC methods, validation protocols and reports, FMEA etc)
  • QA support for licensees
  • Supporting the preparation of both PAION UK and PAION DE for any GxP inspection or Due Diligence by regulatory authorities and Licensees
  • Supporting/hosting GxP inspection or Due Diligence by regulatory authorities and Licensees at both Cambridge and Aachen sites
  • QMS record administration and filling
  • Travel to CMOs/suppliers for audits and to CMOs/suppliers/ Licensees for Quality and technical meetings
  • Occasional travel to Aachen office

Your profile:

  • Bachelors honours degree
  • RSC and CQI or equivalent society approved courses in the following matter titles but not limited to: Auditing, GMP, QA, IMP API a plus
  • Professional/industry experience: up to 3 years working within Quality in the Pharmaceutical and/or Research and development industries
  • Relevant skills and knowledge:
    • Good eye for detail

    • Experience having to follow instructions/procedures
    • Experience working within a QMS

    • Supplier/vendor approval, including site auditing

    • Batch review

    • Practical use of EUDRA/FDA/ICH guidelines and regulations

    • Performing Self-Inspections

    • Deviation/CAPA writing, investigation, and approval

    • Change Control writing and approval/closure

    • Document Control

    • Artwork/Labelling

    • QC - including review/approval of; release testing, method validation Knowledge of Manufacturing Processes

  • Good inter personal skills

  • Good IT software skills

  • Fluent in English

Reference: 37136222

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