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QC Stability Expert

 
 
 
QC Stability Expert

Currently we’re looking for

1

QC Stability Expert
Location: Gdańsk




We are waiting just for you!

What will you do?

  • Main responsible person for Documentation and Standards in QC Polpharma Biologis
  • Ensures that all data in the lab area are accurate and integer on paper and electric records
  • Ensures that all QC documents (plans, reports, results, method, specifications, etc.) are well managed,  consistent and compliant.
  • Reviews  CAPAs, deviations, change controls, OOSs, risk analysis and ensures all records  are closed in a timely manner and according to procedures.
  • Assists owners in CAPA, root cause analysis, deviation investigation, OOS investigations, risk analysis
  • Ensures that the most updated regulation (USP…) is implemented
  • Pull and analyzes metrics to measure effectiveness and makes recommendations
  • Interfaces auditors during inspections, participates to QC internal audit
  • Ensures that all corrective actions from internal and external audits are effective and verified
  • Follows, interprets and develops written Policies and Standard Operating Procedures
  • Monitors internal audit non-conformances, perform trend analyses, and present findings
  • Participates in process improvement activities to continuously improve effectiveness
  • Reviews completed quality records to ensure completeness and adequacy.
  • Participation or lead in documenting, investigating, troubleshooting and preventing recurrence of deviation
  • Represents Polpharma with clients and prospective clients
  • Participation  and representation of Polpharma Biologics in internal/external audits

What do we expect?

  • Higher education in biologics, chemistry, pharmacy, biotechnology or related,  supported by min. 2 years of work experience in the pharmaceutical industry
  • Excellent knowledge of GMP requirements, pharmaceutical laws and regulations for pharmaceuticals, especially for biopharmaceutical drug substance and sterile products and stability studies
  • Knowledge of physicochemical, biological and microbiological methods
  • minimum 2 years of laboratory experience (in regulated environment)
  • Fluent knowledge of spoken and written English

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