Contractor QA Specialist (f/m/d)

Industry:  Pharma
Skills:  Head of Quality, Qualification, Validation (IQ/OQ/PQ)

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:

• Manage qualification and validation processes for a new production line, ensuring compliance with regulatory standards and company policies.
• Coordinate and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Develop and maintain validation master plans, protocols, and reports to support new product introductions and process improvements.
• Collaborate with cross-functional teams to ensure successful implementation of quality processes and validation strategies.
• Conduct risk assessments and gap analyses to identify potential compliance issues and implement corrective actions.
• Participate in client and regulatory audits, addressing audit findings and ensuring timely resolution.
• Support continuous improvement initiatives by analysing quality data, identifying trends, and recommending process enhancements.

Qualifications:

• Bachelor's degree in Chemistry, Biology, Pharmacy, or related field; additional certifications in Quality Assurance or Validation preferred.
• Minimum 5 years of experience in Quality Assurance roles within multiproduct companies and CDMO environments.
• Strong understanding of validation principles, regulatory compliance, and quality systems.
• Proven expertise in qualification and validation of production lines, with a focus on new product introductions.
• Experience in creating and maintaining validation documentation, including master plans, protocols, and reports.
• Excellent problem-solving, analytical, and communication skills.
• Ability to work effectively in cross-functional teams and adapt to changing priorities.