GMP Quality Assurance Associate
LanceSoft UK
slough, england, United Kingdom
Role: QA Associate Location: Slough, Berkshire SL1 4DX Duration: 9-month role with potential to extend Fully onsite position Description: Role Purpose & Scope: Enable site operations performance by managing and supporting GMP issues through QMS processes, site governance and senior QA leadership. Ensure that quality is maintained at an appropriate level meeting customer and regulatory expectations and enable the Slough Site to deliver to relevant targets. This will be achieved by assessing compliance with site PQS and principles of GMP auditing documentation generated during manufacturing processes, development and laboratory processes and where required escalating non-compliance through the PQS, site governance mechanisms and senior QA Leadership. Supporting Senior QA leadership to drive continuous improvement. Maintaining compliance with Regulatory Authorities requirements, Global Quality standards and client s Customer expectations. Key Responsibilities: To provide shoulder to shoulder review of documentation generated during manufacturing processes, development and laboratory processes. Advise areas of support on best practice for document completion, review and follow up actions/ escalate if required. Acting as a point of contact for general queries relating to Quality and escalating as required. Expand and utilize knowledge of quality procedures to identify and report non-conformances and resolve issues arising in the area via interaction with the relevant personnel. Utilize knowledge of GMP and quality processes within the functional areas to manage and escalate major and critical compliance issues through the site QMS processes e.g. deviations and CAPAs. To actively identify, suggest and participate in continuous improvement activities Mentor and coach business partners in cGMP practice to maintain and develop a cGMP environment. Maintain and promote a state of audit readiness. Actively suggest, initiate, participate and contribute to PQS process improvement initiatives and projects. Key Stakeholders: Please specify the stakeholder positions the role will interact with Stakeholder 1 Manufacturing Stakeholder 2 Material Science and Technology (MSAT) Stakeholder 3 Supply Chain Required Skills & Competencies: (e.g. technical, interpersonal, problem solving) Skills IT literate (MS Office Word, Explorer, Excel, Access, Outlook) familiarity with database entries Verbal and written communication skills Risk based decision making PQS experience Accurate data entry skills, high attention to detail Demonstrated workload prioritization skills, decision making and scheduling skills Ability to meet strict deadlines Good organizational and planning skills. Education/Degree Required: Bachelors of Science (or equivalent experience) Field of Study Biology or related field