Production Quality Analysts
- Reference: 68081376
- Location: Ebbw Vale (NP23)
- Salary: From £20,000 to £25,000 per annum
- Type: Full time
Just Life Sciences is an Independent Life Sciences recruiter based in South Wales.
We are seeking two Production Quality Specialists, who ideally are Life Science or Engineering Graduates with 18 months' experience within a GMP or Quality function
The key aim of the role is to drive and support manufacturing operations in all aspects of both Quality and GMP, ensuring that quality standards are both established and maintained.
You will be the Quality Champion within the manufacturing operations team, ensuring that GMP requirements are met.
- To comply with company policies including internal and external Health and Safety and Environmental standards as required.
- To identify self-development needs for future performance.
- To undertake such tasks, and to manage specific internal or ad hoc projects, as and when required to meet department and business needs within the scope of the job-holder’s capabilities and responsibilities.
- Communicate and provide quality expertise within the Manufacturing Operations Area, and other related functional areas.
- Act as an interface to Key Customers in relation to Quality issues and improvements.
- Perform pre-flight verification checks for daily batch start-up activity including first piece inspection.
- Perform daily on-line batch record audits to verify documentation accuracy, equipment suitability, validated parameters, calibration status, product specification, and compliance and completion of on-line challenges.
- Verify customer and testing samples as required by procedure or batch record documentation.
- Investigate customer complaints by inspecting and reporting the condition of retention samples and Batch Documentation.
- Initiate change controls for Equipment, Batch Record documentation, SOPs, and Material Specifications as appropriate.
- Initiate and facilitate Deviation investigation and quarantines
- Review Quality and Production data for completeness, legibility and accuracy.
- Review instrument and packaging booth logs for completeness, legibility and accuracy.
- In conjunction with the Manufacturing Operations Personnel and Quality Management, identify trends and improvement opportunities in Quality, GMP, OEE and Health and Safety, and provide support for the implementation of appropriate preventive measures.
- Perform weekly internal audits and assist in the resolution of issues identified.
Qualifications, Skills and Experience
- Appropriate Engineering or Science-based Degree, or appropriate Vocational Qualifications preferred.
- Demonstrated operations or QA experience, preferably in a GMP regulated environment.
- Knowledge of the relevant testing methodologies.
- A competent knowledge and understanding of the principles of Regulatory issues.
- Clear, concise and courteous inter-personal communication skills.
- Good maths and writing skills.
- Ability to read, comprehend, execute, and communicate written SOPs.
- Honesty and integrity.
Just Life Sciences
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