Quality Specialist
2 weeks ago
**Main Purpose of the Role**:
As a Quality Systems Specialist, you will play a crucial role in ensuring that our Quality Systems adhere to both Regulatory and Company standards. Your primary responsibility will be to provide guidance and support to the Quality function, overseeing the operation of designated Quality Systems. Through your expertise and dedication, you will contribute to maintaining the highest level of compliance and quality within our organization.
**Key Responsibilities**:
**Design and Manage Quality Systems**: Develop, design, and manage various Quality Systems, ensuring they align with Regulatory Standards and Corporate expectations. This includes, but is not limited to:Vendor Assurance
Complaint Management
Product Quality Reviews (PQRs)
Document Control
QMS Systems (e.g., TrackWise, Glorya, SAP Vendor Module)
Internal and External Audit Program
Monitoring QMS performance (KPIs, SQC, Annual Reports)
**Documentation Compliance**: Generate, issue, and oversee the control of CGMP documentation that supports existing Quality Systems and processes.
**Continuous Improvement**: Support the continuous improvement of quality documentation and processes to ensure ongoing compliance with CGMP.
**Training**: Design and deliver CGMP and Quality Systems training, tailored to meet the specific requirements of the site.
**Auditing**: Conduct internal and external audits according to the established plan. Act as a lead auditor, efficiently identifying, addressing, and resolving non-compliance issues within specified timeframes.
**Regulatory Knowledge**: Stay updated on the latest Regulatory standards and ensure dissemination of this information to company personnel.
**Areas of Impact Affecting the Job**:
- Ensuring CGMP Compliance
- Vendors/Suppliers Compliance and Suitability
- Effective Management of QMS Systems
- Streamlined Documentation Review Process
- Annual Review Initiatives
- Efficient Planning, Organization, and Control of Activities
- Alignment with Performance Plan Objectives and Goals
- Prioritization of Daily Workload and Activities
- Day-to-day Issue Resolution Guided by Policy/Procedures
- Implementation of QMS Updates and Projects
**Contact with Others**:
- Collaboration with Internal Departments for CGMP Application and Compliance Updates
- Communication with Vendors/Suppliers
- Interaction with Global Contacts for Compliance Matters
**Decision-Making Authority**:
- Resolving Quality Issues
- Daily Operational Decisions Aligned with Policy and Procedures
- Implementing Changes to Systems and Processes
- Application of CGMP Principles
**Knowledge, Skills, and Abilities**:
- **Knowledge**:Knowledge: Comprehensive Understanding of CGMP
Proficiency in Quality Systems and Documentation
Familiarity with QMS Processes (Change Control, Deviation, CAPA, etc.)
Audit Best Practices
Knowledge of Pharmaceutical GMP Regulations (EU & USA)
- **Skills**:Skills: Strong Numeracy and Literacy Skills
Proficiency in Computer Usage
Excellent Report Writing Skills
Competent Audit Skills
Effective Communication Skills
- **Abilities**:Abilities: Influencing and Presenting
Creative Problem Solving
Efficient Prioritization and Deadline Management
**Qualifications and Accreditations**:
- Relevant Experience in a Quality Role within the Pharmaceutical Industry
- Preferred Graduate Qualification
**Salary**: £3,500.00-£4,200.00 per month
**Benefits**:
- Additional leave
Schedule:
- Monday to Friday
Ability to commute/relocate:
- Runcorn: reliably commute or plan to relocate before starting work (required)
Work Location: In person
Reference ID: #INDEED_C
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