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