Senior Quality Specialist

2 days ago

Runcorn, United Kingdom PE Global Full time

The purpose of this role is to provide guidance and support to the Quality function ensuring designated Quality Systems are operated in compliance with Regulatory and Company standards.

**Role**:

- To design, develop and manage Quality Systems and associated documentation to ensure compliance with Regulatory Standards and Corporate expectations. This includes but is not limited to the following quality systems:
Vendor Assurance
b. Complaint Management
c. PQR’s
d. Document Control
e. QMS Systems - TrackWise, Glorya, SAP Vendor Module etc.
f. Internal & External Audit program
g. QMS performance i.e., KPI’s, SQC, Annual Reports etc.
- To generate, issue and control CGMP documentation to support existing Quality Systems and processes.
- To support continuous improvement of quality documentation and processes to ensure compliance with CGMP.
- To design and deliver CGMP and Quality Systems training in line with Site requirements.
- To carry out internal and external audits in line with plan. To act as lead auditor, to identify, action and close out all non-compliance issues with adherence to schedule.
- To maintain and update information on latest Regulatory standards for use by company personnel.
- CGMP Compliance
- Vendors/Suppliers - compliance and fitness for purpose
- QMS Systems - TrackWise, Glorya, SAP Vendor Module etc.
- Documentation Review Process
- Annual Review
- Planning, Organising and Controlling
- Objectives and goals in line with performance plan
- Day to day work load and prioritisation of activities
- Day to day resolution directed by policy/procedures
- Project planning and implementations for QMS updates and projects impacting both local department and across Site.
- Planning and delivery of QMS training in line with Site support needs.
- Contact with Others
- Vendors/suppliers
- Global Teva Contacts for Compliance
- Decision Making Authority
- Resolution of quality issues
- Day to day need in line with policy and procedures
- Changes to systems and processes
- Application of CGMP

**Requirements**:

- Relevant experience in Quality role within Pharma Industry (ideally approx.3 years experience in a similar role)
- Graduate preferred.
- Document control experience
- Full understanding of cGMP.
- Knowledge of Quality Systems / documentation.
- Knowledge of QMS Processes such as Change Control, Deviation, CAPA etc.
- Audit best practices.
- Knowledge of Pharmaceutical GMP regulations (EU & USA)
- Good numeracy and literacy skills
- Computer literate
- Report Writing skills
- Audit Skills
- Good Communication skills
- Creative Problem Solving skills
- Ability to prioritise effectively and work to tight deadlines

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