QA Specialist

TN United Kingdom; Slough; On-site; GBP 40,000 - 70,000; Full time

Job summary

An innovative organization in the bio-pharmaceutical sector seeks a QA Specialist for a 12-month contract in Slough. This role offers a unique opportunity to advance your career while working on quality and compliance infrastructure development. You will collaborate with various stakeholders to ensure adherence to industry regulations, participate in audits, and contribute to improving compliance processes. Join a supportive company that values its employees and is dedicated to making a positive impact on the lives of those affected by neurological and immunological diseases.

Qualifications

• Several years of pharmaceutical experience in Quality Assurance or Clinical Development.
• In-depth experience with GCP and GVP, including global audits.

Responsibilities

• Assist with the creation of quality and compliance policies and SOPs.
• Collaborate with stakeholders to ensure compliance with regulations.
• Support CAPA activities for internal audits and inspection findings.

Skills

Quality Assurance

GCP (Good Clinical Practice)

SOP Writing

Regulatory Compliance

Clinical Development

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 affected by neurological and immunological diseases, you will be the HPQE in GCSO quality and compliance infrastructure development.

This is a superb opportunity for those looking to advance their career in the field with a supportive and innovative company that prioritizes its employees.

Responsibilities:

1. Assist with creation/revision of 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 regulations, maintaining 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. Contribute to initiatives aimed at improving quality and compliance processes and effectiveness in collaboration with stakeholders.
6. Stay updated on GCP, GLP, regulatory, and industry trends; share key information via professional associations and conferences within GCSO Practice, Global Regulatory Affairs, and Clinical Quality Assurance.
7. Provide GCP, GLP, and PV guidance and training to GCSO staff across all phases of clinical drug development.
8. Support Corrective and Preventive Action (CAPA) activities for internal audits and inspection findings, including CAPA tracking and timely closure.
9. Partner with colleagues to proactively identify and mitigate compliance risks, resolve potential issues, and escalate critical risks to 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 with GCP and GVP, including hands-on experience in global GCP audits and 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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