Contracts Manager (Engineering)

The Recruitment Guy (Pty) Ltd; KwaZulu-Natal; On-site; ZAR 30 000 - 70 000; Full time

Job summary

An established industry player is seeking a meticulous Qualified Person to join their Quality Assurance team. In this pivotal role, you will ensure the timely release of solid oral dosage products while adhering to industry standards and regulations. Your expertise will support high-volume batch releases and compliance with EU legislation and GMP. This dynamic company offers a competitive salary and benefits package, along with opportunities for professional growth and the chance to make a significant impact in the pharmaceutical sector. If you are detail-oriented and passionate about quality assurance, this is the perfect opportunity for you.

Benefits

Competitive salary

Bonus

Pension schemes

Holiday benefits

Qualifications

• Qualified to act as a certified QP with practical experience in a UK pharmaceutical setting.
• Experience certifying multiple dosage forms and familiarity with MHRA GMDP inspections.

Responsibilities

• Check GMDP compliance and review deviations and authorisations.
• Verify quality checks, conduct inspections, and maintain documentation.
• Represent the company during inspections and contribute to continuous improvement.

Skills

EU legislation knowledge

GMP compliance

Quality checks and audits

Attention to detail

Communication skills

Education

Degree in life science

Job description

Role Details

Qualified Person

Role: Full-time, Permanent

Location: Fawdon, Newcastle upon Tyne

Salary: Competitive + bonus + benefits

The Role

We are seeking a meticulous and pragmatic Qualified Person (QP) to join our Quality Assurance team. Reporting to the Associate Director of Quality, you will support the high-volume batch release of our solid oral dosage products, ensuring timely release in compliance with marketing authorisations and industry standards.

Your responsibilities include:

1. Checking site GMDP compliance, including production and distribution conditions and manufacturing records.
2. Reviewing deviations and planned change authorisations.
3. Verifying and performing quality checks, sampling inspections, and audits.
4. Investigating complaints to ensure corrective and preventative actions (CAPAs).
5. Maintaining the PQS system and departmental documentation, including SOPs, technical agreements, and reports.
6. Representing the company during inspections and participating in quality meetings.
7. Contributing to continuous improvement initiatives, new product launches, and training of junior staff.

The Person

Qualified to act as a certified QP, with practical experience in a UK pharmaceutical setting. Candidates should have:

1. Comprehensive knowledge of EU legislation and GMP, especially in high-volume environments.
2. Experience certifying multiple dosage forms; solid dose and sterile experience are advantageous.
3. Experience with product transfers and MHRA GMDP inspections is beneficial.
4. A logical, organized approach, with keen attention to detail.
5. Excellent communication skills, confident liaising with stakeholders at all levels.
6. A degree in a life science subject.

The Rewards

We offer a competitive salary and benefits package, including holiday, bonus, and pension schemes. Join us and make a meaningful difference in a dynamic, expanding company with international reach.

How to Apply

Interested candidates should complete their profile on our careers site. The closing date for applications is 01/12/2024.

About Us

Accord Healthcare Europe is a rapidly growing pharmaceutical company, selling medicines in over 80 countries. We are committed to improving access to affordable medicines and supporting healthcare professionals worldwide. We value innovation, diversity, and professional growth.

Join us to advance your career and make a difference.

Equal Opportunity

We consider all applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.