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Job Title: Associate Principal QA Specialist - Global Biopharmaceutical
Contract: 12 months
Location: Slough (Hybrid, 2 days onsite after training period)
Salary: 30.77 PAYE, 40.47 Umbrella per hour (Inside IR35)
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.
