Overview
Quality Assurance Specialist Jobs in Slough, England, United Kingdom at SRG
Title: Quality Assurance Specialist
Company: SRG
Location: Slough, England, United Kingdom
- Job Title -Associate Principal QA Specialist
- Location –Slough
- Contract Length – 12 months
- 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 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.
Required Skills & Competencies
- 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.
- Strong Continuous Improvement mindset
- Excellent communication skills (verbal and written).
- Ability to meet strict deadlines.
