Qpip (Quality Person in Plant)
il y a 5 jours
**Introduction**:
- Join our innovative biotechnology company, where we develop life-saving cell therapies.
**Job description**:
- Act as a quality lead within the facility to support cell therapy manufacturing.
- Ensure quality control and oversight of process activities.
- Perform periodic quality checks/audits on processes, documentation, and adjustments.
- Reduce non-conformances and deviations by actively promoting compliance.
- Conduct real-time review of process documentation to support operations and product release.
- Collaborate with staff to resolve manufacturing issues.
- Timely processing, investigation, and review of deviations, CAPAs, change requests, and complaints.
- Approve production procedures and batch records.
- Perform tasks in compliance with safety policies, quality systems, and cGMP requirements.
- Support inspections and audits by ensuring inspection readiness.
- Conduct internal audits and other assigned tasks.
**Profiel**:
- Education:
- Bachelor’s or Master’s degree in Science, or relevant experience in the pharmaceutical industry.
**Experience**:
- Relevant work experience, preferably in an aseptic manufacturing facility within quality assurance, manufacturing compliance, or cell therapy, is an asset.
Skills and Knowledge:
- Proficiency in aseptic operations in ISO 5 cleanrooms and biosafety cabinets.
- Knowledge of cGMP regulations, FDA/EU guidelines, and Good Tissue Practices.
- Detail-oriented, organized, and capable of working autonomously within a team.
- Strong written and verbal communication skills.
- Problem-solving skills and leadership capabilities.
- Willingness to work in shifts, including evenings and weekends.
**Offer**:
- Competitive salary.
- Permanent contract with an indefinite duration.
- Commuting allowance.
- Meal vouchers.
- Group insurance & hospitalization insurance.
- Shift premiums.
- Opportunity to grow within a developing company.
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