Lead Quality Assurance Specialist
vor 2 Monaten
Lonza is seeking a highly skilled Lead Quality Assurance Specialist to join our team in Visp, Switzerland. As a key member of our Quality Assurance team, you will be responsible for ensuring the highest standards of quality and compliance across our sites and facilities.
Key Responsibilities- Provide quality assurance support for project and operations internal customers in areas such as GMP & Compliance, Cold-chain, supply chain, good warehousing practice, and clean utilities.
- Ensure quality assurance oversight of site and facilities, focusing on shared utility systems and logistics areas.
- Organize and lead deviation review boards for utilities & logistics related deviations.
- Review and assess change requests and corrective and preventative actions (CAPA).
- Review and approve standard operation procedures for shared utility systems and logistics.
- Review and assess GMP impact of utility and cold-chain alarms and incidents.
- Assist with operational readiness activities and assess their risks in relevant areas.
- Support internal and external audits, inspections, and represent the Quality function at relevant meetings.
- Lead or support local implementation of global Quality policies and standards in your area of responsibility.
- Academic degree (Bachelor or higher) in Pharmaceutical Sciences, Biochemistry, Engineering, Chemistry, or related field.
- Relevant work experience in Quality Assurance and/or Production, Engineering, and/or Quality Control in pharmaceutical industries and cGMP-controlled environments.
- Knowledge of Swiss, EU, and US GMP regulations relevant to audit/inspections and compliance systems.
- Strong verbal and written communication skills (English required, German is helpful).
- Ability to communicate quality and compliance requirements to varying levels and functions of the organization.
- Strong collaborative mindset and the ability to build relationships quickly.
- Strong organizational skills, and ability to balance multiple priorities simultaneously.
- Ability to solve problems, understand details and strategic picture, providing practical solutions.
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