GDP QA Specialist in Guildford

The GDP QA Specialist is responsible for ensuring compliance with GDP requirements and approved procedures at all times. This role will be working 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, collaborating with other departments to ensure SOP’s 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, facilitate delivery of training.

What We Do

Essential Pharma is a global pharmaceutical company working to make a difference for patients in niche populations. Everything at Essential Pharma is driven by the fact that every patient matters. We are focused on developing and delivering medicines for patients in small, underserved or rare disease populations. Our team of 70+ people has an entrepreneurial spirit, challenging convention and working creatively to deliver results. Our headquarters are in Surrey, UK, and we have offices in Malta, France, Spain and Switzerland. We are an international business, with a growing product portfolio that reaches patients in approximately 70 countries. We cover multiple therapy areas with a particular focus on rare disease, CNS, ophthalmology and gastroenterology. Our first development-stage asset is an anti-GD2 antibody for the treatment of high-risk neuroblastoma. We have a proven track record of acquiring, investing in and commercialising treatments.

What You Will Bring

• Qualifications: Degree in Pharmacy, Chemistry, Biology.
• Previous GDP Training.
• 2 Years working within GDP Environment.
• Experience in Pharmaceutical distribution requirements.
• Handling Export process in EU and ROW.

Core Competencies

• Strong Agile thinker who can adapt to situations of high-speed change.
• Problem solver who can work through complex issues.
• Candidate must demonstrate a Growth mindset and willingness to learn.
• Must demonstrate integrity and high ethical standards.
• Previous demonstration of working effectively as part of a team with strong collaboration.
• Demonstrates a willingness to achieve goals together and respect the view of others.
• Results orientated and accountable for actions.

What We Offer

• Competitive salary.
• Office-based contracts with flexibility on locations of work when required and appropriate.
• £150 towards your home office.
• Healthcare Pension – you contribute 5% and we offer 5%.
• Life Insurance – lump sum (tax free) death benefit of 4 x basic salary.
• Enhanced family leave.
• Enhanced sick pay.
• 25 days annual leave.
• Discretionary annual performance bonus.

What To Expect

At Essential Pharma, every colleague matters: we want every member of the team to thrive and grow during their time with us. Right from the interview stage, we encourage candidates to ask us questions, voice opinions and be curious. This is a dynamic, fast-paced working environment. We expect individuals to be responsible and accountable, while understanding the importance of collaborating with colleagues to fuel success. We pride ourselves on our inclusive culture, based on the belief that everyone brings unique strengths and perspectives. We have an unwavering dedication to employee growth and development.