Senior QA Specialist

Vor 5 Tagen

Visp, Schweiz Lonza Vollzeit

Job Summary:

The QA Infrastructure and Logistics group provides key QA oversight and support for the site. This group supports the site utilities, warehousing, and movement of raw materials and products in and out of facilities.

Key Responsibilities:

  • Provide QA support for Project and Operations internal customers in the following areas: Regulatory Compliance, Cold Chain Management, Supply Chain Optimization, Good Warehousing Practice, and Clean Utilities.
  • Provide Quality Assurance oversight to the 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 Operating 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 the relevant areas.
  • Support internal and external audits, and inspections and represent the Quality function at relevant meetings.
  • Lead or support local implementation of global Quality policies and standards in his/her area of responsibility.

Requirements:

  • 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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