Associate Principal QA Specialist

Job Title: Principal QA Specialist – Global Biopharmaceutical

Contract: 12 months

Location: Slough (onsite) – potential for hybrid after training complete

Salary: £31.99 PAYE, £40.47 Umbrella per hour (Inside IR35)

Hours: 37.5 hours per week

Reports to position*

QA Manager (QA Technical Support)

Job Title*

Associate Principal QA Specialist, QA Technical Operations

Primary Location*

Slough

Role Purpose & Scope*

(why does this job exist and what scope does it cover?)

• 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 our clients Customer expectations

Key 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
• Performs other duties as assigned.

Key Metrics*

KPI Targets (in addition to abiding relevant quality systems standards (ISO 9001, ISO 13485) & where relevant complying to applicable pharmaceutical GMP standards (US and European) / 21CFR820 as well as abiding & role modelling for all Health, Safety and Environmental rules and guidelines)

• Deviation assessment completed within 2 days
• Zero overdue quality records

Key Stakeholders*

Please specify the stakeholder positions the role will interact with

• Manufacturing Operations (Cell Banking, Fermentation, Purification and Manufacturing Support)
• Warehouse and Supply Chain

Required Skills & Competencies*

(e.g. technical, interpersonal, problem solving)

• 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.

• Qualifications (Min. requirements to perform assigned tasks)

Education/Degree

Field of Study – Scientific

Language(s)

Required*

English

2 – Business Fluent

Work Experience

Area*

Quality (QA or QC)

Level*

Advanced – 5-10 years