Associate Principal QA Specialist

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.