Job Description
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