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if you want to work:

in one of the most modern biotechnology
centres in Europe
 
in place where profesionals
from all over the world work
on the highest-quality equipoment
 
in the production
of biotechnological
drugs, which dive access
to effective therapy to
more patients
 
in a company that will dive you stable employment competetive remuneration attracive benefits and the opportunity to participate in training at home and abroad
 
Currently we’re looking for
QC Stability Expert

Join “start-up” Biologics division with strong international and local team at site!

 

 
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
Aplikuj