QA Specialist – 5417 ADA
Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a Quality Assurance Specialist for a 1-year contract, with possible extension, based in the Valais area, Switzerland.
• Monitoring, trending, reviewing of compliance critical functions including quality systems, change control, training, internal audit, document control, deviation, corrective and preventive actions, regulatory and customer audit program for the site.
• Monitor Quality Performance and trends Quality Events of the site.
• Work with the Compliance Lead and other Department Managers to ensure timely closure of all quality events such as change controls, non-conformances, investigations, corrective / preventive actions (including audit commitments), and effectiveness checks.
• Analyse and present Quality related metrics reports, data and Key Performance Indicators (KPIs)
• Investigate non-product related non-conformance with the required personnel / department on site to develop CAPA and effectiveness checks.
• Frequent review into the Quality Events to ensure the Quality Events are completed to the level as required.
• Participate in the Quality Risk Management Program and Assessment. Work with the Quality Risk Management team to develop Quality Risk Assessment Reports
• Work with the Compliance Lead to evaluate new Global Quality Standards and implement locally where appropriate.
• Participate in the internal audit programs as internal auditor, when required.
• Provide training in key areas of Quality System performance and compliance to continuously improve overall knowledge of the site in quality systems and develop behaviors that contribute to GMP activities.
• Maintains the GMP documents in the Documentum in a GMP compliant manner.
• Communicate potential quality risks / issues based on trends / observations to the management team.
• Support in the Development and maintenance of Department Policies, SOPs, and other documents to ensure compliance to client’s Global Quality Standards
• Work with team members and department managers to evaluate and identify gaps on regulatory guidelines.
• Identify improvement opportunities in the Quality Compliance related areas.
Qualifications and Experience:
- Relevant Swiss working/residency permit or Swiss/EU-Citizenship required;
- Direct QA commercial drug substance/drug product experience required.
- GMP compliance knowledge preferred.
- Excellent written and oral communication to include accurate and legible documentation skills; ability to work in a fast-paced environment; team oriented; independent work skills and a strong work ethic.
- The ability to interface and communicate directly with clients is required.
- Microsoft Office and database management skills, organization skills, record keeping skills and ability to handle multiple projects.