Quality Assurance Manager
Vor 2 Tagen
TN Switzerland is a global leader in life sciences operating across three continents.
Role Overview:The Quality Assurance (QA) Infrastructure and Logistics group provides key QA oversight and support for the company's sites. This group supports site utilities, warehousing, and movement of raw materials and products in and out of facilities.
This position will focus on implementing and managing robust cross-functional support of legacy and new facilities. You will be responsible for assuring Quality Assurance of the company's sites and facilities, while ensuring shared utility systems and logistics areas are carried out by the company's standards, industry best practices, and regulatory requirements.
Key Responsibilities:- Provide QA support for internal customers in the following areas: GMP & Compliance, Cold-chain, supply chain, 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 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 the relevant areas.
- Support internal and external audits, and inspections and represent the Quality function at relevant meetings.
- 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).
- Ability to communicate quality and compliance requirements to varying levels and functions of the organization.
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