GDP QA Specialist

GDP QA Specialist

Full-Time 36000 - 60000 £ / year (est.) No home office possible
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Essential Pharma

At a Glance

  • Tasks: Ensure compliance with GDP requirements and support distribution QA activities.
  • Company: Join Essential Pharma, a global leader in patient-centric pharmaceutical solutions.
  • Benefits: Enjoy competitive salary, flexible work options, healthcare, and generous leave.
  • Why this job: Make a real impact in a fast-paced environment focused on patient care.
  • Qualifications: Degree in Pharmacy, Chemistry, or Biology; 2 years in a GDP environment.
  • Other info: Collaborative culture that values growth, diversity, and innovation.

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

The GDP QA Specialist is responsible for ensuring compliance with GDP requirements and approved procedures at all times. This role will work in close collaboration with the QA Director distribution, RP's and QA. This position will provide completion of documents and processes to help the business objectives and deliver on targets related to distribution QA activities. The position will also be integral to inter-departmental communication to ensure all requirements are met.

What You Will Do

  • Collation & completion of RP/RPi release documents and checklists (UK/EU/CH).
  • Exports monitoring and control.
  • Customer qualification / requalification.
  • Documentation, monitoring of key milestones and approval process.
  • Ensure lane risk assessments are in place and accurate for all export customers.
  • Support and lead Distribution SOP updates.
  • Collaborate with other departments to ensure SOPs include key GDP compliance requirements.
  • Facilitate collation & completion of returns documents to ensure timely handling for RP disposition.
  • Support operational QA activities, maintaining logs accurately and contemporaneously.
  • Deviation and CAPA investigations and actions.
  • Change control processing - Change Actions oversight per delegation of the RPs.
  • Identify training needs for the team members and facilitate delivery of training.

Qualifications

  • Degree in Pharmacy, Chemistry, Biology.
  • Previous GDP Training.
  • 2 years working within a GDP environment.
  • Experience in pharmaceutical distribution requirements.
  • Handling export processes in the EU and ROW.

Core Competencies

  • Strong agile thinker who can adapt to high-speed change.
  • Problem solver who can work through complex issues.
  • Growth mindset and willingness to learn; integrity and high ethical standards.
  • Team player with strong collaboration and respect for others' views.
  • Results-oriented and accountable for actions.

About Essential Pharma

Essential Pharma is a global pharmaceutical company focused on making a difference for patients in niche populations. Our mission is patient-centric, with a team of 70+ people driving entrepreneurial spirit and innovation. Our headquarters are in Surrey, UK, with offices in Malta, France, Spain and Switzerland. We operate internationally, with a growing product portfolio reaching patients in approximately 70 countries and focus areas including rare disease, CNS, ophthalmology and gastroenterology. Our first development-stage asset is an anti-GD2 antibody for high-risk neuroblastoma, and we have a track record of acquiring, investing in and commercialising treatments.

What To Expect

We value every colleague and support growth and development. From the interview stage, candidates are encouraged to ask questions, share opinions and be curious. A dynamic, fast-paced environment requires responsibility, accountability, and collaboration. We maintain an inclusive culture and believe diverse strengths and perspectives contribute to success.

Benefits

  • Competitive salary
  • Office-based contracts with flexibility on work location where appropriate
  • £150 towards your home office
  • Healthcare
  • Pension: match 5% employee contribution
  • Life Insurance: lump sum death benefit of 4 x basic salary
  • Enhanced family leave
  • Enhanced sick pay
  • 25 days annual leave
  • Discretionary annual performance bonus

GDP QA Specialist employer: Essential Pharma

Essential Pharma is an exceptional employer that prioritises patient-centric values and fosters a dynamic, inclusive work culture. With a commitment to employee growth, we offer competitive salaries, flexible work arrangements, and comprehensive benefits, including enhanced family leave and generous annual leave. Join our innovative team in Surrey, where your contributions directly impact the lives of patients across the globe, and thrive in an environment that encourages collaboration and continuous learning.
Essential Pharma

Contact Detail:

Essential Pharma Recruiting Team

StudySmarter Expert Advice 🤫

We think this is how you could land GDP QA Specialist

✨Tip Number 1

Network like a pro! Reach out to people in the industry, especially those already working at Essential Pharma. A friendly chat can open doors and give you insider info on what they're really looking for.

✨Tip Number 2

Prepare for the interview by brushing up on GDP compliance and export processes. Show us you know your stuff and can hit the ground running. We love candidates who are ready to dive into the details!

✨Tip Number 3

Don’t just wait for the job to come to you! Apply through our website and make sure to follow up. A little persistence goes a long way in showing us you're genuinely interested in joining our team.

✨Tip Number 4

Be yourself during the interview! We value authenticity and want to see how you fit into our culture. Share your experiences, ask questions, and let your personality shine through.

We think you need these skills to ace GDP QA Specialist

GDP Compliance
Documentation Skills
Export Process Management
Risk Assessment
SOP Development
Deviation and CAPA Investigations
Change Control Processing
Training Facilitation
Collaboration Skills
Analytical Skills
Problem-Solving Skills
Attention to Detail
Agility in Fast-Paced Environments
Results-Oriented Mindset

Some tips for your application 🫡

Tailor Your CV: Make sure your CV is tailored to the GDP QA Specialist role. Highlight your relevant experience in GDP environments and any specific training you've had. We want to see how your background aligns with our needs!

Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about joining Essential Pharma and how you can contribute to our patient-centric mission. Keep it concise but impactful!

Showcase Your Problem-Solving Skills: In your application, don’t forget to mention examples of how you've tackled complex issues in previous roles. We love agile thinkers who can adapt and find solutions, so let us know how you fit the bill!

Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team!

How to prepare for a job interview at Essential Pharma

✨Know Your GDP Inside Out

Make sure you brush up on Good Distribution Practice (GDP) regulations and how they apply to the pharmaceutical industry. Be ready to discuss specific examples from your previous experience that demonstrate your understanding and compliance with these standards.

✨Showcase Your Collaboration Skills

Since this role involves working closely with various departments, prepare to share instances where you've successfully collaborated with others. Highlight your ability to communicate effectively and how you’ve contributed to team success in past roles.

✨Be Ready for Problem-Solving Scenarios

Expect questions that assess your problem-solving skills, especially in relation to complex issues in a GDP environment. Think of a few challenging situations you've faced and how you navigated them, focusing on your thought process and the outcomes.

✨Ask Insightful Questions

Prepare thoughtful questions about the company’s approach to GDP compliance and how they handle training and development. This shows your genuine interest in the role and helps you gauge if the company culture aligns with your values.

GDP QA Specialist
Essential Pharma
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