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Senior Analytical Operations Manager
2 months ago
Permanent Position
Salary: £56-70k (Dependent on Experience)
SRG is collaborating with a leading global organization in the medical products and technologies sector. This role involves providing essential technical and analytical development support for the T&I pipeline projects.
Key Responsibilities:
• Oversee and prioritize the analytical testing program, ensuring effective planning, coordination, and execution of all testing activities.
• Ensure that methodologies and validation processes adhere to internal protocols, comply with relevant regulations and guidelines, and align with industry best practices.
• Actively lead the Analytical team, fostering effective communication, engagement, recruitment, employee development, and performance management.
• Responsible for achieving targeted Key Performance Indicators (KPIs) and monitoring team performance, while maintaining the highest standards of safety and compliance in line with EHS policies and laboratory quality systems.
• Collaborate with project and departmental managers to efficiently manage workloads, timelines, and departmental priorities.
• Support equipment qualification in accordance with established procedures, including software validation activities for the implementation of equipment software packages.
• Identify and resolve Out of Specification (OOS) issues and non-conformances related to analytical testing, procedures, and processes.
• Provide technical support and guidance to manufacturing sites and contribute as a vital member of the R&D team in Design & Development projects under Design Controls.
Qualifications:
• Bachelor's Degree or higher in a relevant scientific discipline.
• A minimum of 7 years of industry experience within a regulated Med Dev/Pharmaceutical laboratory environment.
• Proficient understanding of compliance with FDA and European regulations concerning Quality Systems.
• Strong Microsoft Office skills are essential.
• Competent in reviewing and approving testing protocols, validation documents, technical reports, Standard Operating Procedures (SOPs), and Technical Documents (TDs).
• Solid experience in utilizing computerized systems for data management to enhance the efficiency of the Analytical testing function.
• Ability to understand the impact of issues identified in one study on the overall project and provide coaching to team members to support their ongoing development.
• Set clear expectations, offer guidance, and recommend areas for improvement and training.
