Compliance Engineer

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 Impact You Will Make

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. 

Kindeva is an Equal Opportunity Employer