SRG • Slough, Berkshire SL1 4DX
About this role
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Job title
Associate Principal QA Specialist
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Location
Slough
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Contract Length
12 months
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Working Hours
37.5 hours/week
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Pay Rate
up to £32.76 p/h DOE
About the Role
- 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 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 escalate critical compliance issues through the QMS.
- Conduct audit trail reviews.
- 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
- Perform additional duties as assigned.
Skills/education
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Education/Degree
Field of Study Scientific
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Work Experience
Quality (QA or QC) Level- Advanced - 5-10 years
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Top three must have experience
QA Manufacturing experience, TrackWise records experience (Deviations, Change controls, CAPA's, investigations) OOS investigations
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Nice to have experience
Audit experience
Guidant, Carbon60, Lorien & SRG - The Impellam Group Portfolio are acting as an Employment Business in relation to this vacancy.