QA Specialist

QA Specialist - HIRING ASAP

Start date: ASAP
Duration: 12 Months
Location: Onsite in Slough
Rate: £313.21 per day inside ir35

Summary:

Support Operations to ensure Compliance to GMP Manage and support GMP issues through QMS processes, site governance and senior QA leadership.
Act as a GMP SME by implementing, managing, and enforcing quality processes on site.
Supporting Senior QA leadership to drive continuous improvement and 'fitness for purpose'.
Maintaining compliance with Regulatory Authorities requirements, Global Quality standards and Lonza's Customer expectations

Skills:

• Previous experience as QA approver of Deviations, CAPAs, Change Controls, OOSs
• Excellent decision-making and problem-solving skills.
• Strong Quality mindset
• Strong business and interpersonal skills and be a persuasive communicator in written, oral, and active listening to influence peers and colleagues.
• Strong Continuous Improvement mindset
• Excellent communication skills (verbal and written).
• Ability to meet strict deadlines.
• Excellent organizational and planning skills.

Responsibilities:

• To provide shoulder to shoulder review, approval, and support to key business partners for the management of quality records eg 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 eg 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.
• Performs other duties as assigned.