Compliance Engineer

Mountsorrel, ENG, GB, United Kingdom

Job Description

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.

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.



#LI-AC1



Kindeva is an Equal Opportunity Employer

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Job Detail

  • Job Id
    JD3763089
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Mountsorrel, ENG, GB, United Kingdom
  • Education
    Not mentioned