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Quality Systems Lead
1 week ago
To lead a team that collectively, is responsible for administering and delivering the Pharmaceutical Quality System (PQS) across the Morpeth facility.
Maintain and develop systems and processes that proactively keep the site ahead of the curve in changes to legislation, technology and risk-based approaches.
Key Roles/Responsibilities Include:
- Lead and develop a team to deliver a robust, supportive, Quality System for the organisation that complies with ICH (Q7, Q9 & Q10), CFR 210 & 211, EU GMP and UK GMP.
- In conjunction with the Head of Compliance and Technical Quality, manage and develop the following systems and processes on site:
- Deviations
- Investigations (using RCA tools)
- CAPAs
- Change Controls
- Effectiveness Reviews
- Extension Requests
- Internal Audit (formal selfinspection and informal Gemba)
- External Audit (by clients and regulatory authorities)
- Quality Complaints
- Product Quality Reviews
- Quality Technical Agreements
- Quality Risk Management
- Quality Metrics and KPIs
- Risk Register and Assessments
- Self-Inspection Audits
- Periodic GMP Training
- Is considered to be the Subject Matter Expert for many of the aforementioned areas.
- Support the following activities:
- Document Control
- Vendor Assurance
- Customer projects and audits
- Pest Control provisions
- Audit / Inspection readiness
- Act as the site's Data Integrity Compliance Officer, tracking any remediation activities, driving improvements, and ensuring ALCOA+ considerations are integrated into the fabric of how we operate.
- Identify, risk assess and remediate any deficiencies relating to the PQS.
- Participate in local and sitewide audits and inspections, acting as a Subject Matter Expert, where appropriate.
- Keep abreast of and maintain systems in line with changing regulations and industry expectations.
Benefits:
- Company pension
- Cycle to work scheme
- Employee discount
- Enhanced maternity leave
- Enhanced paternity leave
- Flexitime
- Free parking
- Life insurance
- Onsite parking
- Private medical insurance
- Referral programme
Schedule:
- Day shift
- Flexitime
- Monday to Friday
Supplemental pay types:
- Bonus scheme
- Performance bonus
Ability to commute/relocate:
- Morpeth: reliably commute or plan to relocate before starting work (required)
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