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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.
* Support Senior QA leadership to drive continuous improvement.
* Maintain compliance with Regulatory Authorities requirements, Global Quality standards, and client’s Customer expectations.
Key Responsibilities:
* Provide review of documentation generated during manufacturing, development, and laboratory processes.
* Advise on best practices for document completion, review, follow-up actions, and escalate if necessary.
* Act as a point of contact for general Quality-related queries and escalate as required.
* Identify and report non-conformances, resolve issues via interaction with relevant personnel, utilizing knowledge of GMP and quality processes.
* Manage and escalate compliance issues through the site QMS, including deviations and CAPAs.
* Participate in continuous improvement activities.
* Mentor and coach business partners in cGMP practices to maintain a compliant environment.
* Maintain audit readiness.
* Contribute to PQS process improvement initiatives and projects.
Key Stakeholders:
Interactions with:
* Manufacturing
* Material Science and Technology (MSAT)
* Supply Chain
Required Skills & Competencies:
* IT literacy (MS Office – Word, Explorer, Excel, Access, Outlook) and familiarity with database entries
* Verbal and written communication skills
* Risk-based decision making
* PQS experience
* Accurate data entry skills, high attention to detail
* Workload prioritization, decision making, and scheduling skills
* Ability to meet strict deadlines
* Good organizational and planning skills
Education/Degree:
* Required: Bachelor of Science (or equivalent experience) in Biology or a related field
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