Quality Assurance Specialist FTC 6 months

Hyper Recruitment Solutions; Greater London; On-site; GBP 60,000 - 80,000; Full time

Job summary

In einer dynamischen und regulierten Umgebung suchen wir einen erfahrenen Quality Assurance Specialist, der die Qualität und Compliance in der pharmazeutischen Herstellung sicherstellt. Diese spannende Rolle erfordert fundierte Kenntnisse in GMP und GDP sowie praktische Erfahrung in der Qualitätssicherung. Sie werden verantwortlich sein für die Implementierung von Qualitätssystemen, die Durchführung von Audits und die Unterstützung bei der Entwicklung elektronischer Qualitätssysteme. Wenn Sie motiviert sind und eine Leidenschaft für Qualität und regulatorische Einhaltung haben, freuen wir uns auf Ihre Bewerbung für diese herausfordernde Position.

Qualifications

• Erfahrung in der Qualitätssicherung in der pharmazeutischen Industrie.
• Vertrautheit mit GMP und GDP Vorschriften.

Responsibilities

• Implementierung und Aufrechterhaltung von Qualitätssystemen in der pharmazeutischen Produktion.
• Durchführung von Gap-Analysen und Unterstützung bei der kontinuierlichen Verbesserung.

Skills

Qualitätsmanagement

Regulatorische Einhaltung

GMP

GDP

Change Controls

CAPAs

Risikobewertung

Kommunikationsfähigkeiten

Tools

Q-Pulse

Microsoft Excel

Job description

Quality Assurance Specialist FTC 6 months

We are seeking an experienced Quality Assurance Specialist with a strong background in pharmaceutical manufacturing and regulatory compliance. The ideal candidate will have hands-on experience in Quality Assurance (QA) roles within the UK pharmaceutical industry and a deep understanding of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) regulations.

Key Responsibilities:

• Implement and maintain quality systems within pharmaceutical manufacturing sites in compliance with UK regulatory requirements.
• Conduct gap analyses on Quality Management Systems (QMS), prepare reports, and provide recommendations for continuous improvement.
• Support Quality Management in enhancing QMS processes, including Change Controls, CAPAs, Deviations, audits, risk assessments, and customer complaint investigations.
• Assist in the review and approval of batch production records to ensure compliance with Marketing Authorisation specifications.
• Develop and maintain Standard Operating Procedures (SOPs) and other quality documentation.
• Conduct root cause analyses and ensure investigations align with regulatory expectations.
• Support the development and implementation of electronic Quality Management Systems (eQMS), such as Q-Pulse (experience with such systems is beneficial).
• Assist in reviewing and updating key SOPs, ensuring alignment with regulatory requirements and internal quality standards.
• Undertake and develop risk assessments as required.
• Generate and analyze quality metrics, utilizing Microsoft Excel at an advanced level.
• Deliver training and coaching to staff on quality processes and regulatory requirements.

Key Skills & Experience:

• Proven experience in Quality Assurance roles within multiple UK pharmaceutical companies.
• Strong working knowledge of GxP regulations and pharmaceutical quality systems.
• Experience in continuous improvement initiatives related to Quality Systems.
• Ability to interpret regulatory guidelines and apply them effectively in a manufacturing environment.
• Strong organizational skills with the ability to prioritize workload and manage multiple tasks effectively.
• Self-motivated, detail-oriented, and capable of working independently.
• Excellent communication and collaboration skills, with experience in training and coaching.

This role offers an opportunity to contribute to a dynamic and regulated environment, ensuring compliance and quality excellence in pharmaceutical manufacturing. If you have the required experience and skills, we encourage you to apply.

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Quality Assurance

Industries

Pharmaceutical Manufacturing