Compliance Engineer

Kindeva Drug Delivery; United Kingdom; On-site; GBP 40,000 - 55,000; Full time

Job summary

A leading pharmaceutical company in the UK is seeking a Compliance Engineer to drive quality compliance and improve processes within the inhalation value stream. This role involves managing documentation, supporting audits, and coaching teams to enhance compliance. The ideal candidate has production experience in a regulated environment and strong communication skills. An attractive compensation package and opportunities for development are offered.

Benefits

Attractive compensation package

Company pension scheme (up to 10% employer contribution)

25 days holiday plus bank holidays

Private Medical Insurance

Employee Assistance Program

Life assurance of four times salary

Flexible working hours

Employee recognition program

Free on-site parking

Qualifications

• Production experience in a regulated environment.
• Ability to investigate quality incidents and conduct root cause analysis.
• Confidence to communicate effectively with people at all levels.

Responsibilities

• Manage documentation for manufacturing and review completed batch records.
• Support internal and external audits for the manufacturing team.
• Coach and mentor others to improve compliance across departments.

Skills

Attention to detail

Excellent written communication

Excellent verbal communication

Problem-solving skills

Education

Degree in Science or Engineering

Tools

Knowledge of D365

Knowledge of Master Control

Job description

Overview

Kindeva Drug Delivery

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The compliance team is responsible for quality compliance improvement within the value stream. The Compliance Engineer will provide technical support to the Inhalation value stream focusing on driving compliance and improving processes.

Role Responsibilities

• Documentation management for manufacturing including reviews of completed batch records and procedure authoring and updates.
• Management of change control process as a subject matter expert supporting other functions.
• Support of internal and external audits for the manufacturing team.
• Collaboration across site teams to ensure quality including site metrics and improvements.
• Support of planned and unplanned deviations, including root cause investigations and CAPAs.
• Support or complaint investigation processes where appropriate.
• Coaching and mentoring others to improve compliance across departments.
• Provide day-to-day support and problem-solving knowledge to the value stream when an issue arises.

Basic Qualifications

• Production experience in a regulated environment.
• Attention to detail for reviewing and updating documentation.
• Excellent written and verbal communication skills and confidence to communicate effectively with people at all levels.
• Ability to investigate quality incidents and root cause analysis.

Preferred Qualifications

• Degree in a Science or Engineering discipline.
• Pharmaceutical product knowledge and experience, preferably inhalers
• Knowledge of pharmaceutical quality management systems.
• Understanding of GMP, Regulatory and ISO standards.
• Knowledge of D365 and Master Control.
• Knowledge of Six Sigma and Lean Manufacturing.

What we Offer

• Attractive compensation package.
• Company pension scheme (up to 10% employer contribution).
• 25 days holiday per year (plus bank holidays) plus service days after 5 years.
• Private Medical Insurance.
• Company sick pay.
• Employee Assistance Program with 24/7 confidential helpline support for employee and immediate family.
• Life assurance of four times life cover salary.
• Flexible working hours.
• Wellness programmes.
• Employee recognition program.
• Employee development.
• Free on-site parking.
• Discount and cashback at many retailers.
• Cycle to work scheme.
• Flu vaccinations.
• Employee referral scheme.

Additional Information

Working Hours: 37.5hrs per week

Location: Derby Road, Loughborough

All applicants must be eligible to work in the UK.

We believe our people make the difference at Kindeva, we look for skilled, passionate, and driven professionals to come and work with us to help us excel in manufacturing technologies and processes, which bring lifesaving products to patients worldwide.

Kindeva is an Equal Opportunity Employer