QA Lead

3 weeks ago

Loughborough, United Kingdom Marketplace Technical Full time

Leading Analytical Development company seeks an experienced Quality Assurance Lead

**About the role**:
The post holder will assess and improve the Pharma Quality System and contribute to GMP compliance and quality operations associated with the development and manufacture of pharmaceutical products for human use

**Duties may include**:

- Monitor and review manufacturing, analytical, stores & distribution, and engineering operations to assess ongoing GMP compliance and quality of manufactured and released pharmaceutical products.
- Plan, perform and report on internal audits.
- Assist and participate in audits of external suppliers as well as assist in hosting customer and regulatory audits as required.
- Participate in the supplier management process to assure that materials are of appropriate quality for pharmaceutical manufacturing.
- Actively assist all departments in the generation of quality system documentation such as change control, deviation investigations, suspect analytical results, risk assessments and quality technical agreements.
- Champion and lead process improvement initiatives to identify and implement more compliant and efficient processes.
- Compile and report on quality system metrics to identify trends and drive improvement.
- Act as an internal/external contact for queries related to product compliance and quality.
- Review and approve master batch records, executed production batch records and associated supporting documentation.
- Review production and laboratory data, which is used to release product, or review validation/stability reports to ensure that all information contained within, is correct and accurate.
- Provide specialist QA support to new product introduction, business projects and continuous improvement initiatives.
- Support, mentor and coach new and existing QA Officers.

**Skills and experience**:

- Significant experience in a Quality role within a Pharmaceutical Quality System.
- Previous experience in writing and producing detailed reports
- Direct experience in the manufacture of solid oral dosage products
- Quality Risk Management
- Root Cause Analysis

**Job Type**: Permanent

**Salary**: £30,000.00-£40,000.00 per year

Schedule:

- Day shift
- Monday to Friday

Ability to commute/relocate:

- Loughborough: reliably commute or plan to relocate before starting work (required)

**Experience**:

- GMP: 1 year (preferred)
- Auditing: 1 year (preferred)
- Quality assurance: 1 year (preferred)
- Mentoring: 1 year (preferred)

Work Location: In person

Reference ID: MATECBB876

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