Quality Assurance Manager

Description:

Lead the QA operations team to drive the quality improvement and remediation objectives for Dechra Skipton ensuring customer and regulatory requirements are met for all product types and markets. Including leads change projects, and upskilling other teams to support this plan.

Drive the quality improvement and remediation objectives for Dechra Skipton ensuring customer and regulatory requirements are met for all product types and markets.

Ensure the batch release process is in compliance to MA, National Law compliance and following Annex-16 guidelines.

Work with the other Dechra Skipton Teams to support customer challenges, always providing an effective solution to our customer’s problems every time.

To coach and mentor the QA operations support team as part of their personal development.

Main Responsibilities

So, what will you be doing? This role has a broad and varied remit and the successful candidate will have responsibility for duties including:

• To drive a quality improvement and remediation objectives to improve compliance and reduce quality issues, reworks and batch failures. To promote a quality culture across the site by liaising with cross functional teams and introducing improvement activities such as ‘Human Factors’ etc.
• To define quality standards of manufacture, pack and GMP at all times to those expected and required by the business and our customers.
• To participate in and provide support to both internal and external audits, including regulatory agency inspections (MHRA, FDA, EMA, etc.)
• To ensure all factory documentation is compliant with customer and regulatory requirements.
• To ensure cGMP is maintained at the Dechra Skipton site.
• To provide guidance for higher level decisions required for change management and deviation investigations, as required.
• Support Supplier Assurance programme including external audits of suppliers to provide assurance that all materials are sourced from approved suppliers
• Provide expert statements for MA variation submissions and recall or other compliance related expert statement generation and management.