Contractor Quality Assurance Generalist (f/m/d)

Industry:  Pharma
Skills:  Qualification / Validation QM, Quality Assurance, Manufacturing

Start of project: 01.05.2024 - 01.06.2024

Duration of the project : 6 months

Project volume: 1008 Hour(s) 

Location: Solothurn/Biel, Switzerland

Tasks:

• Manages material introduction, supplier qualification, and component management, setting up quality and regulatory strategies on site.
• Coordinates site inspections, oversees transformation for new production, and ensures readiness for client and regulatory audits.
• Monitors local regulation updates, conducts gap analysis, and ensures site practice meets regulatory requirements.
• Leads quality agreement processes with customers, suppliers, and service providers; drives Quality Management Review and continuous improvement initiatives.
• Administers Quality Risk Management, maintains the Quality Risk Register, and participates in cross-functional projects to enhance site quality and client experience.
• Engages in hosting client and regulatory audits, ensuring timely and effective execution of audit commitments.
• Collects quality data, analyses compliance performance trends, and identifies opportunities for continuous improvement.

Qualifications:

• At least Bachelor's degree in Chemistry, Biology, Pharmacy, or related field; additional certifications in Quality Assurance or Regulatory Affairs preferred.
• Minimum 5 years of Quality Assurance experience in CDMO companies, with a track record in introducing new quality processes, risk management.
• Practical knowledge in GMPs and Regulatory Compliance.
• Strong understanding of regulatory compliance in pharmaceutical or biotech industries; experience in fixing compliance issues.
• Proven expertise in creating and maintaining quality documentation, including SOPs, quality agreements, and regulatory submissions.
• Demonstrated problem-solving and analytical skills, with the ability to drive continuous improvement initiatives.
• Experience in leading cross-functional teams and participating in client and regulatory audits.
• Excellent communication skills, both written and verbal.