Valspec
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The Compliance Coordinator is responsible for overseeing validation deviations, CAPAs, change controls, and supporting validation activities in a pharmaceutical environment. This role involves coordinating audits, managing equipment maintenance, and ensuring compliance with inspection standards.
The role involves supporting clients by providing technical expertise in automation systems, troubleshooting, implementing change control procedures, managing event reports, and leading continuous improvement initiatives in the life sciences sector.
The MBR Author will be responsible for PAS-X MES design, development, and documentation within biopharmaceutical environments. Duties include gathering user requirements, configuring electronic batch records, developing qualification documentation, and supporting the implementation of system updates. The role requires experience in the SDLC of automated computer systems especially in the context of life sciences.
As an MES Engineer at Valspec, you will implement and validate Manufacturing Execution Systems (MES), particularly Emerson's Syncade. Your role involves configuring MES solutions to optimize client manufacturing processes, ensuring compliance with regulatory standards, and providing technical support during system upgrades and troubleshooting.
The Quality Engineer will develop and implement quality control and assurance strategies for cell and gene therapy products, perform risk assessments, review technical documents, conduct audits, and ensure compliance with regulatory requirements. They will also troubleshoot quality issues and collaborate with cross-functional teams on quality improvement initiatives.
Valspec is accepting general applications and referrals for future job openings. Candidates may have an initial phone screening with a Talent Relationship Manager if a suitable position arises. The company offers a supportive work environment and competitive benefits, aiming to keep candidates in their database for future considerations.