Qualified Person 10571

A Bit About Us; KwaZulu-Natal; On-site; ZAR 40 000 - 80 000; Full time

Job summary

Join a dynamic and expanding pharmaceutical company as a Qualified Person, where you'll play a vital role in ensuring compliance and quality in the release of solid oral dosage products. This position offers a unique opportunity to contribute to continuous improvement and best practices in a high-volume environment. With a focus on collaboration and mentorship, you'll work alongside a dedicated Quality Assurance team, ensuring that all products meet the highest standards. This is your chance to make a meaningful impact in a growing international business committed to improving access to vital medicines.

Benefits

Holiday

Pension schemes

Bonus

Qualifications

• Eligible to act as a certified Qualified Person with practical QP experience.
• Comprehensive knowledge of EU legislation and GMP regulations.

Responsibilities

• Support high-volume batch release of solid oral dosage products.
• Check site GMDP conditions and perform quality checks.

Skills

GMP regulations

Quality Assurance

Communication skills

Attention to detail

Education

Degree in Life Science

Job description

Role Details

Qualified Person

Role: Full-time Permanent

Location: Fawdon, Newcastle upon Tyne

Salary: Competitive + bonus and 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 support the high-volume batch release of our solid oral dosage products, ensuring all batches are released in a timely manner in accordance with marketing authorisations and compliance requirements.

Your responsibilities include checking site GMDP conditions, reviewing deviations and change authorisations, performing quality checks, investigating complaints, and ensuring CAPAs are implemented.

You will maintain our PQS system and documentation, including SOPs, technical agreements, and management reports, ensuring ongoing compliance and performance monitoring.

Additionally, you'll represent the company during inspections, participate in Quality team meetings, and collaborate with Quality colleagues across the Accord network.

In line with our Continuous Improvement ethos, you'll contribute to new product launches, promote a Quality mindset, and help establish best practices at the Fawdon site. This may involve monitoring departmental output and mentoring junior staff.

The Person

• Eligible to act as a certified Qualified Person with practical QP experience in a UK pharmaceutical setting.
• Comprehensive knowledge of EU legislation and GMP regulations, with experience in high-volume environments.
• Experience certifying multiple dosage forms is beneficial; solid dose and sterile experience are advantageous.
• Experience with product transfers and MHRA GMDP inspections is a plus.
• Logical, organized, detail-oriented, with excellent communication skills.
• Degree in a life science subject is required.

The Rewards

We offer a competitive salary and benefits package, including holiday, bonus, and pension schemes. Join us to make a meaningful impact within a dynamic, expanding business with international reach.

How to Apply

If you're passionate and capable, please complete your Candidate Profile on our careers site. The closing date is 01/12/24.

About Us

Accord Healthcare Europe is one of Europe's fastest-growing pharmaceutical companies, with a presence in over 80 countries. We are committed to improving access to vital medicines and supporting healthcare professionals worldwide. We value innovation, inclusivity, and professional growth. Join us to advance your career and make a difference.

All applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.