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Associate Principal QA Specialist

Slough
3 weeks ago
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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 vacancy

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