QA Specialist

Quanta part of QCS Staffing; Slough; On-site; GBP 45,000 - 60,000; Full time

Job summary

A leading bio-pharmaceutical organization is seeking an experienced QA Specialist for a 12-month contract in Slough. The role involves developing quality policies, ensuring compliance with industry regulations, and supporting audits and inspections. This is an excellent opportunity for career advancement in a supportive environment focused on innovation.

Qualifications

• Several years of pharmaceutical experience in Quality Assurance or Clinical Development.
• In-depth experience of GCP and global GCP audits.
• Experience in SOP writing is essential.

Responsibilities

• Assist with creation and revision of quality and compliance policies and SOPs.
• Collaborate to ensure compliance with GCP, GLP, and related regulations.
• Participate in audit and inspection planning and execution.

Skills

Quality Assurance

GCP

Compliance

Pharmacovigilance

SOP Writing

Job description

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QA Specialist – Bio-pharmaceutical - Slough

We are looking for an experienced QA Specialist for a fantastic 12-month contract based in Slough.

Working with our client, a global bio-pharmaceutical organization committed to improving the lives of people afflicted with neurological and immunological diseases, you will serve as the HPQE in GCSO quality and compliance infrastructure development.

This is a superb opportunity if you are looking to advance your career in the field with a supportive and innovative company that prioritizes its employees.

Responsibilities:

1. Assist with creation/revision of appropriate quality and compliance policies, Standard Operating Procedures (SOPs), processes, and best practices as needed.
2. Collaborate with Clinical Development Quality, Patient Safety, Regulatory Affairs, strategic partners, and other stakeholders to ensure compliance with ICH GCP, GLP, PV, and relevant local and international regulations, and to ensure inspection readiness.
3. Participate in audit and inspection planning with Clinical Development Quality and Pharmacovigilance Quality Assurance.
4. Represent or ensure GCSO representation and preparation during audits/inspections (on-site by internal and external parties).
5. Attend improvement initiatives to enhance quality and compliance processes and effectiveness in collaboration with stakeholders.
6. Stay informed about GCP, GLP, regulatory, and industry trends. Share key information gathered via professional associations and conferences (upcoming regulations, best practices) within GCSO Practice, Global Regulatory Affairs, and Clinical Quality Assurance.
7. Provide GCP, GLP, and PV guidance and training to GCSO staff for all phases of clinical drug development.
8. Support Corrective and Preventive Action (CAPA) activities for internal audits and findings from any audits and inspections, including CAPA tracking and monitoring for timely closure.
9. Partner with colleagues to proactively identify and mitigate compliance risks, resolve potential observations, and escalate critical risks to the Clinical Quality Management Lead.

Required experience:

1. Several years of pharmaceutical experience, preferably in a global Quality Assurance or Clinical Development setting.
2. In-depth experience of GCP and GVP, including hands-on experience in global GCP audits and/or inspections.
3. A couple of years of experience in SOP writing is essential.

If this role interests you, please apply now.

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