Title: Qualified Person
Role Details
Qualified Person
Role: Full time, Permanent
Location: Fawdon, Newcastle upon Tyne
Salary: Competitive + bonus + benefits
The Role
We’re seeking a meticulous and pragmatic Qualified Person (QP) to join our Quality Assurance team. Reporting to our Associate Director of Quality, you’ll help support the high-volume batch release function of our solid oral dosage format products, ensuring all product batches are released in a timely manner, in-line with the provisions of each product’s marketing authorisation, along with company and industry compliance requirements. Your responsibilities will range from checking site GMDP (including production and distribution conditions and manufacturing records), reviewing deviations and planned change authorisations, verifying and performing quality checks (including sampling, inspections and audits) and investigating any complaints to ensure appropriate corrective and preventative actions (CAPAs) are taken. You’ll ensure our PQS system and all departmental documentation remains current and compliant at all times, including standard operating procedures (SOPs), technical agreements and reports for management to monitor departmental data and identify any performance trends. To support the wider business, you’ll represent the company at inspections, attend regular Quality team meetings and establish good working relationships with your Quality colleagues across the Accord network. In alignment with our Continuous Improvement ethos, you’ll contribute to new product launch plans, foster a Quality mindset across all departments and help establish best practice quality processes for the Fawdon site; this may include monitoring our departmental output and engaging in training or mentoring more junior colleagues, as required.
The Person
- Eligible to act as a certified Qualified Person (experienced or newly qualified), with practical QP experience in a UK pharmaceutical setting, certifying product to market.
- Comprehensive knowledge of relevant EU legislation, particularly around good manufacturing practice (GMP), with experience working in a fast-paced, high volume environment.
- Experience certifying multiple dosage forms would be beneficial, but solid dose and steriles experience would be beneficial.
- Experience of product transfers and hosting MHRA GMDP inspections advantageous.
- Takes a logical and organised approach to work, following procedures with a keen eye for detail.
- Excellent communication skills (written and spoken), confident liaising with stakeholders at all authority levels, building lasting relationships in multi-cultural environments and comfortable exercising your negotiating and influencing skills, as required.
- A degree-level qualification in a life science subject is required for this role.
How to Apply
If you possess the experience, passion and ability to make this role a success then we would like to hear from you. Please complete your Candidate Profile on our careers site to apply for this role. The closing date is 02/06/24. For more information, you can contact us on: careers@accord-healthcare.com
A Bit About Us
Accord Healthcare Europe is one of the fastest growing pharmaceutical companies in Europe. Accord has one of the largest market footprints of any European generic and biosimilars companies selling generic medicines in over 80 countries around the world. This global footprint enables us to deliver vital, affordable medicines to national health systems supporting healthcare professionals to transform patient lives worldwide. The approach of Accord is agile and inventive, always seeking to improve products and patients' access to them. Accord are driven to think differently and deliver more for the benefit of patients worldwide.
To continue our growth, we’re looking for the best and brightest technical minds and forward-thinking business professionals. Keeping our people at the heart of all we do, we offer rewarding opportunities for those looking for continued personal and professional growth, investing in training and development tailored to each individual’s focus. So, if you’re looking for an inclusive company to take your career to the next level, you’re certainly in the right place; come and join us to make it better.
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