Qualified Person 10571

A Bit About Us; Newcastle; On-site; ZAR 300,000 - 600,000; Full time

Job summary

An established industry player is on the lookout for a meticulous Qualified Person to join their Quality Assurance team. This dynamic role involves ensuring timely batch releases of solid oral dosage products while adhering to regulatory compliance and company standards. As part of a progressive and expanding business, you will play a key role in fostering a quality mindset, conducting audits, and representing the company during inspections. With a competitive salary and rewards package, this is a unique opportunity to make a significant impact within a growing international organization that values personal and professional development.

Benefits

Competitive salary

Bonus

Pension scheme

Holiday

Qualifications

• Eligible to act as a certified Qualified Person with practical QP experience.
• Comprehensive knowledge of EU legislation and GMP in a fast-paced environment.

Responsibilities

• Support high-volume batch release function ensuring compliance with regulations.
• Conduct quality checks, audits, and investigations to uphold product standards.

Skills

Qualified Person certification

Knowledge of EU legislation

Good manufacturing practice (GMP)

Excellent communication skills

Attention to detail

Problem-solving skills

Education

Degree in life sciences

Job description

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 multicultural 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.

The Rewards

In return, we offer a competitive salary and rewards package (including holiday, bonus, and pension scheme). Not to mention the opportunity to genuinely make a difference in a new and dynamic role within a progressive and expanding business at an exciting time of growing international reach.

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 01 / 12 / 24. For more information, you can contact us on:

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 is 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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All applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.

Requisition ID: 10571