QA Specialist

QA Specialist

Slough Full-Time 36000 - 60000 £ / year (est.) No home office possible
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At a Glance

  • Tasks: Join a global bio-pharmaceutical team as a QA Specialist, ensuring quality and compliance.
  • Company: Work with a leading organisation dedicated to improving lives through innovative treatments.
  • Benefits: Enjoy a supportive work environment with opportunities for career advancement and professional growth.
  • Why this job: Be part of a mission-driven company that values its employees and fosters innovation.
  • Qualifications: Must have several years in pharmaceutical QA, GCP experience, and SOP writing skills.
  • Other info: This is a 12-month contract based in Slough, perfect for those looking to make an impact.

The predicted salary is between 36000 - 60000 £ per year.

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 organisation committed to improving the lives of people afflicted with neurological and immunological disease, you will be 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 will put you first.

Responsibilities:

  • Assist with creation/revision of appropriate quality and compliance policies, Standard Operating Procedures (SOPs), processes, and best practices as needed.
  • Work in collaboration with Clinical Development Quality, Patient Safety, Regulatory Affairs, strategic partners, and other stakeholders to ensure compliance with International Council for Harmonisation of Technical Requirements for Pharmaceutical for Human Use (ICH) GCP, GLP, PV and relevant local and international regulations and to ensure inspection readiness.
  • Participate in Audit and Inspection planning with Clinical Development Quality and Pharmacovigilance Quality Assurance.
  • Represent or ensure GCSO representation and preparation during audits/inspections (on-site by internal and external parties).
  • Attend improvement initiatives to improve quality and compliance processes and effectiveness in collaboration with stakeholders.
  • Stay abreast with GCP, GLP, regulatory, and industry trends. Share key information gathered via professional associations and conferences (upcoming regulations, best practices) within the GCSO Practice, Global Regulatory Affairs, and Clinical Quality Assurance.
  • Provide relevant GCP, GLP, and PV guidance and training to GCSO staff for all phases of clinical drug development.
  • Support Corrective and Preventive Action (CAPA) activity for internal (system) audits and findings from any audits and inspections where findings are raised to our client in conjunction with department managers and subject matter experts. This includes CAPA tracking and monitoring for timely closure.
  • Partner with colleagues/others to (proactively) identify and mitigate compliance risks, resolve potential compliance observations and escalate critical compliance risks to Clinical Quality Management Lead.
  • Required experience:

  • Several years of pharmaceutical experience, preferably in a global Quality Assurance or a Clinical Development setting.
  • In depth experience of GCP and GVP, including hands on experience in global GCP audits and/or inspections.
  • Couple of years of experience in SOP writing essential.
  • If this role is of interest, please apply now.

    #LI-JS4

    QA Specialist employer: Quanta part of QCS Staffing

    Join a leading global bio-pharmaceutical organisation in Slough, where your expertise as a QA Specialist will be valued and nurtured. With a strong commitment to employee development, a collaborative work culture, and a focus on innovation, this company offers a unique opportunity to contribute to meaningful advancements in healthcare while enjoying a supportive environment that prioritises your professional growth.
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    Contact Detail:

    Quanta part of QCS Staffing Recruiting Team

    StudySmarter Expert Advice 🤫

    We think this is how you could land QA Specialist

    ✨Tip Number 1

    Network with professionals in the bio-pharmaceutical industry, especially those who work in Quality Assurance. Attend relevant conferences or webinars to meet potential colleagues and learn about the latest trends in GCP and GLP compliance.

    ✨Tip Number 2

    Familiarise yourself with the specific regulations and guidelines that govern the bio-pharmaceutical sector. Being well-versed in ICH GCP, GLP, and PV will not only boost your confidence but also demonstrate your commitment to compliance during interviews.

    ✨Tip Number 3

    Prepare for potential interview questions by reviewing common scenarios related to audit and inspection processes. Think of examples from your past experience where you successfully managed compliance risks or contributed to CAPA activities.

    ✨Tip Number 4

    Showcase your SOP writing skills by discussing specific instances where you created or revised policies. Highlight how your contributions improved quality and compliance processes, as this is a key requirement for the role.

    We think you need these skills to ace QA Specialist

    Quality Assurance Expertise
    Knowledge of GCP and GLP
    Experience in SOP Writing
    Audit and Inspection Preparation
    Regulatory Compliance Knowledge
    Collaboration Skills
    Attention to Detail
    Problem-Solving Skills
    CAPA Management
    Training and Guidance Provision
    Risk Assessment and Mitigation
    Communication Skills
    Adaptability to Regulatory Changes
    Industry Trend Awareness

    Some tips for your application 🫡

    Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the QA Specialist position. Familiarise yourself with GCP, GLP, and relevant regulations to tailor your application accordingly.

    Highlight Relevant Experience: In your CV and cover letter, emphasise your pharmaceutical experience, particularly in Quality Assurance or Clinical Development. Mention specific projects or audits you've been involved in that relate to the job description.

    Showcase SOP Writing Skills: Since SOP writing is essential for this role, provide examples of your experience in creating or revising Standard Operating Procedures. Detail any specific processes you have developed or improved.

    Tailor Your Application: Customise your CV and cover letter to reflect the skills and experiences mentioned in the job description. Use keywords from the listing to ensure your application stands out to hiring managers.

    How to prepare for a job interview at Quanta part of QCS Staffing

    ✨Know Your Regulations

    Familiarise yourself with ICH GCP, GLP, and PV regulations. Be prepared to discuss how these regulations impact quality assurance processes and share examples from your past experiences.

    ✨Showcase Your SOP Writing Skills

    Since SOP writing is essential for this role, come prepared with examples of SOPs you have created or revised. Highlight your approach to ensuring clarity and compliance in your documentation.

    ✨Demonstrate Collaboration Experience

    This position requires collaboration with various stakeholders. Be ready to discuss specific instances where you successfully worked with cross-functional teams to enhance quality and compliance.

    ✨Prepare for Audit Scenarios

    Expect questions about your experience with audits and inspections. Prepare to discuss how you contributed to audit readiness and any challenges you faced during previous audits, along with how you overcame them.

    QA Specialist
    Quanta part of QCS Staffing
    Location: Slough
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