Associate Principal QA Specialist

JR United Kingdom; London; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading company in the biopharmaceutical sector is seeking an Associate Principal QA Specialist in London. The role involves ensuring compliance with GMP, managing quality records, and mentoring colleagues. This position offers the opportunity to contribute to quality processes and continuous improvement in a dynamic environment.

Qualifications

• Excellent decision-making and problem-solving skills.
• Strong quality mindset and interpersonal skills.
• Effective communication skills in verbal and written forms.

Responsibilities

• Review, approve, and manage quality records like Deviations and CAPA.
• Mentor and coach colleagues in cGMP practices.
• Maintain audit readiness.

Skills

Decision-making

Problem-solving

Quality mindset

Interpersonal skills

Effective communication

Organizational skills

Job description

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Associate Principal QA Specialist, London

Client: SRG

Location: London, United Kingdom

Job Category: Other

EU work permit required: Yes

Job Views: 4

Posted: 31.05.2025

Expiry Date: 15.07.2025

Job Description:

Job Title: Principal QA Specialist – Global Biopharmaceutical

Contract: 12 months

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

Hours: 37.5 hours per week

Reports to: QA Manager (QA Technical Support)

Job Title: Associate Principal QA Specialist, QA Technical Operations

Primary Location: Slough

Role Purpose & Scope

This role exists to support operations in ensuring compliance to GMP, managing GMP issues through QMS processes, and acting as a GMP SME to implement and enforce quality processes on site. It also involves supporting continuous improvement, maintaining regulatory compliance, and fostering a quality culture.

Key Responsibilities

• Review, approve, and support management of quality records such as Deviations, CAPA, Change Controls, Investigations, OOS.
• Manage and escalate compliance issues through site QMS processes.
• Identify, suggest, and participate in continuous improvement activities.
• Mentor and coach colleagues in cGMP practices.
• Maintain audit readiness.
• Participate in PQS process improvements and projects.
• Support QA activities at departmental meetings and during manufacturing out of hours.
• Perform other duties as assigned.

Key Metrics

Deviation assessments completed within 2 days, among other KPIs aligned with quality standards and regulatory requirements.

Key Stakeholders

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

Skills and Qualifications

• Excellent decision-making and problem-solving skills.
• Strong quality mindset and interpersonal skills.
• Effective communication skills in verbal and written forms.
• Ability to meet strict deadlines and excellent organizational skills.