* Job Title - Associate Principal QA Specialist
* Location – Slough
* Pay Rate- 32.76 p/h
Role and Responsibility
* Provide QA review and oversight for various studies and activities.
* Support a culture of quality and continuous improvement within QC and Development Services.
* Support Operations to ensure ongoing compliance with GMP.
* Manage and support GMP issues through QMS processes, site governance and senior QA leadership.
* Act as a GMP Subject Matter Expert (SME) by implementing, managing and enforcing quality processes on site.
* Support senior QA leadership in driving continuous improvement and ensuring processes are ‘fit for purpose’.
* Ensure compliance with GMP requirements within Development Services.
* Maintain compliance with Regulatory Authority expectations, Global Quality Standards and Lonza customer requirements.
Key Responsibilities
* Provide shoulder-to-shoulder review, approval and support for deviations, CAPAs, change controls, investigations and OOS records.
* Review QA activities for MSAT studies, pilot studies, and Development Services.
* Review QC activities including method validation, reference standards and stability studies.
* Manage and elevate critical compliance issues through the QMS.
* Perform area walkthroughs to identify and resolve non-compliance.
* Audit raw data, protocols and validation reports for GMP compliance.
* Maintain and promote audit readiness.
* Ensure protocols and validation reports are approved according to project schedules.
* Lead process audits and support GMP audit activities.
* Identify and participate in continuous improvement initiatives.
* Support quality governance via Local Quality Councils and project meetings.
* Provide QA SME support for Operations, QC, MSAT and Development Services.
* Mentor and coach business partners in GMP practices.
* Advise scientists on documentation and follow‑up expectations.
* Provide out‑of‑hours QA support where required.
* Act as a GMP SME enforcing site quality processes.
* Excellent decision‑making and problem‑solving skills.
* Strong Quality mindset
* Strong business and interpersonal skills and be a persuasive communicator in written, oral and active listening to influence peers and colleagues.
* Excellent communication skills (verbal and written).
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