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Associate Principal QA Specialist
Job Posted: 3 hours ago
Salary: £ 30.99 - 31.99 / Hour
Job Type: Contract
Location: Slough, Berkshire
Expire in: a month
Job Description
Job Title: Associate Principal QA Specialist
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
1. Job Details
Supervisory Organization*
QA Technical Operations
Reports to position*
QA Manager (QA Technical Support)
Job Title*
Associate Principal QA Specialist, QA Technical Operations
Job Profile
N/A
Primary Location*
Slough
Additional Location(s)
None
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*
(define specific short & long-term work duties starting with the most frequent and impactful)
· 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*
Organization Size
(# of direct/indirect reports)
Financial responsibility
(e.g. budget, Revenue)
0
None
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.
2. Qualifications (Min. requirements to perform assigned tasks)
Education/Degree
Required*
Scientific
Field of Study
Scientific
Preferred
N/A
Field of Study
N/A
Language(s)
Required*
English
Ability Level
2 - Business Fluent
Preferred
N/A
Ability Level
Choose an item.
Certifications (incl. professional qualifications) i.e. ACCA, GPHR, CIPS, PgMP
Required
N/A
Issuer
N/A
Preferred
N/A
Issuer
N/A
Work Experience (If UK location - NO years of experience should be included)
Area*
Quality (QA or QC)
Level*
Advanced - 5-10 years
Area
N/A
Level
Choose an item.
Other Requirements
· None
Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancyBefore You Apply
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