Associate Principal QA Specialist

Hours: 37.5 hours per week

The Associate Principal QA Specialist will Manage and support GMP issues through QMS processes, site governance and senior QA leadership. They will also Act as a GMP SME by implementing, managing and enforcing quality processes on site.

Job Responsibilities:

• To provide shoulder to shoulder review, approval and support to key business partners for the management of quality records e.g. Deviations, CAPA, Change Controls, Investigations, OOS.
• Utilize knowledge of GMP and quality processes within the functional areas to manage and escalate major and critical compliance issues through the site QMS processes e.g. deviations and CAPAs
• To actively identify, suggest and participate in continuous improvement activities
• Mentor and coach business partners in cGMP practices to maintain and develop a cGMP environment and quality culture
• Maintain and promote a state of audit readiness
• Actively suggest, initiate, participate and contribute to PQS process improvement initiatives and projects
• Provide QA SME support at departmental Local Quality Councils and project meetings
• Provide QA SME Support for manufacturing during out of hours

Essential Requirements:

• BSc in Science or QA discipline.
• Previous experience as QA approver of Deviations, CAPAs, Change Controls, OOSs
• Has the personal determination to make performance happen with people not in reporting lines.
• Excellent decision making skills.
• Ability to meet strict deadlines.
• Excellent organisational and planning skills.
• Ability to streamline/ lean processes. Be open-minded with the enthusiasm and motivation to learn, improve and innovate.
• Demonstrates an ability to see the big picture.
• Excellent communication skills (verbal and written).
• Believes diversity creates strength within the team.
• Embraces and creates collaborative relationships.
• Has the clarity of thought to deliver clear unambiguous communication.

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.