Job Description

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia, and the Americas.

Due to our continuous growth, we are looking for a highly experienced Quality Systems and Compliance Executive Consultant with a minimum of 10 years of relevant experience , fitting the following mandatory skill-set and willing to work in Indianapolis, Indiana, US.

Responsibilities:

• Define strategies and lead initiatives to improve and sustain the effectiveness of batch disposition execution
• Assess, identify, and execute (where possible) workload management solutions related to change controls, or other quality-impacting projects
• Act as a consultant and executor for Materials Management oversight in relation to Customer Complaints (CARTS), and supply chain process improvements
• Provide technical guidance for deviations within the quality unit

Requirements:

• Extensive experience applying cGMPs to drug products and combination products, with a focus on deviation management, change control, and materials management
• Strong project management skills, including scheduling, resourcing, and escalation handling, with the ability to support resource development
• Proficiency in batch disposition processes
• Experience managing non-conformances and overseeing change controls
• Proven leadership skills to mentor and coach operational and support personnel on quality matters, with a strategic external perspective
• Excellent communication skills to effectively coordinate with various departments and ensure that all team members are aligned with the quality objectives and project goals
• Demonstrated experience in continuous improvement, with the ability to assess and work cross-functionally to identify solutions for the areas outlined above

Next Steps

Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview. If there's a positive match, a technical interview with the Hiring Manager will be arranged. In the case of a positive feedback coming from the Hiring Manager interview, the recruiter will contact you for the next steps or to discuss our proposal. Alternatively, if the feedback is negative, we will contact you to halt the recruitment process.

Working at PQE Group

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world. If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you. Apply now and take the first step towards an amazing future with us.

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