Quality& Qc Manager, Gmp/gdp

2 weeks ago

Runcorn, United Kingdom Russell Taylor Full time

**Quality& QC Manager, GMP/GDP**

**Location**: Runcorn

**Type**: Permanent

**Salary**: upto £55,000 depending on experience

**Additional**: 5% matched pension, life assurance (x4), company bonus (upto 5%), private medical, enhanced sick pay and income protection scheme

**Hours**: Monday - Friday (days)

**The Role**:
Manages the quality assurance and quality control activities related to assigned products on daily basis, ensuring compliance to relevant regulations and customer requirements.

**QA/QC duties**:

- Responsible to qualify and release products based on a documentation verification and QC results (where applicable) in compliance with applicable regulations and relevant quality standards
- Overseas QC analytical work, methods execution & results evaluation (e.g., APR)
- Provides expert guidance to ensure continuous qualification of existing products and supports development of new portfolios; ensures data management and its validity (respect of data integrity rules)
- Validates manufacturer's certificates of analysis (CoA) and creates CoA's for customers, as well as other required statements
- Collaborates with external laboratories for sample analysis if applicable
- Responds to quality related customer request (questionnaires, documentation audits, quality technical agreements etc.)
- Supports internal organizations to ensure customer satisfaction
- Handles complaints related to product quality; oversees distribution service complaints and provides support if needed
- Enforces regulatory compliance within the organization
- Responds to internal colleagues for any type of technical product-related questions
- Leads organizes and prepares the site for Quality Audits requested by customers and regulatory bodies.
- Participates in organization and preparation of Quality Audits of product and/or services suppliers

**QMS**:

- Engages with European Quality Team (ability to work in a matrix organization)
- Responsible for the management of the Clients UK QMS
- Works on continuous improvement of the existing processes and shares ideas about process improvement
- Leads and contributes to process and procedure review and improvement internally and at EU level; ensures their deployment at site level.
- Monitors validity of existing certificates (GMP/ GDP/ ISO/ HACCP etc.) provided by the suppliers (maintenance of Supplier Qualifications)
- Executes work in line with the established internal rules and Standard Operating Procedures (SOP) and ISO norms
- Monitors changes in product related data sets
- Undertakes PQR's at pre-determined intervals
- Executes assigned training (QMS) and overseas the training performance of local team.
- Organizes and oversees execution of QA & QC tasks on day-to-day basis.
- Provides Management Information and analysis to enable the compliance of the QMS to be visible to the Site Leadership and the wider EU organisation.

**The Person**:

- **Will hold a degree in a relevant / Scientific field**:

- Will have worked in a senior quality role for a related industry (Cosmetics, Nutrition, API, Chemical etc).
- Will have five years' plus experience in a similar role; managing a QMS and working closely with QC.
- Experience in audit hosting/ preparation and QMS preservation and adherence
- Leadership / line management experience required.
- Strong interpersonal skills

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