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.
- 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.
- Performs other duties as assigned.
