Specialist - QA Pharma Complaints

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Schaffhausen, Switzerland

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Cilag AG in Schaffhausen belongs to the group of Johnson & Johnson Innovative Medicine and manufactures high quality pharmaceutical products, active pharmaceutical ingredients (APIs) and medical devices. Today Cilag AG is one of the largest pharmaceutical manufacturers in Switzerland supplying all the major global markets. The Schaffhausen facility is a strategic launch and growth site for parenteral products, and we have an impressive pipeline of new and innovative products.

We are searching for the best talent to join us as a Specialist - QA Pharma Complaints in Schaffhausen, Switzerland.

Purpose:

In this role, you will lead Product Quality Investigations based on feedback from patients and customers. This feedback is a critical signal for potential product quality risks and opportunities for continuous manufacturing process improvement. You will investigate these potential quality concerns in close collaboration with internal Manufacturing, Quality Control, Engineering, and device design experts. You will support quality activities for both new and existing products and ensure compliance with applicable regulatory and quality standards. You will work closely with multiple internal stakeholders and will be involved in documentation review, quality audit support, and data analysis. Through daily interaction with Quality, Laboratory, Manufacturing, Engineering, and Regulatory teams, you will gain a strong end‑to‑end understanding of the pharmaceutical product lifecycle.

You will:

• Investigate product quality concerns based on customer complaints.
• Assessment, coordination and/or investigate assigned customer complaints
• Inspect returned products, investigation of technical details, and root cause analysis, risk assessment, and assist/lead associated CAPA investigations
• Ensure accurate documentation and closure of each complaint in order to make and document sound regulatory reporting decisions.
• Develop a detailed understanding of the products and previously investigated complaints.
• Evaluate of market impact of new complaints and escalate critical issues for immediate action.
• Review and analyse complaint information for trending/risk analysis and corrective actions and resultant effectiveness of these actions.
• Support internal, external, and third-party audits.
• Support additional project team activities and/or investigations, and participate in process improvement projects.

Qualifications / Requirements:

• A Masters's Degree, PhD or equivalent experience in engineering, physical, biological, natural sciences is required.
• Strong written and verbal communication skills in English.
• Investigative & analytical critical thinking skills.
• Strong decision-making skills - able to make sound business decisions with sometimes limited information.
• 1 year of experience in quality in a pharma/medical device or other regulated industry is preferred but not required.
• Knowledge of statistical applications and auditing practices is preferred but not required.

At Johnson & Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time.

Here's what you can expect:

• Application review: We'll carefully review your CV to see how your skills and experience align with the role.

• Getting to know you: If there's a good match, you'll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.

• Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.

• Final steps: For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide you through these.

Finally, at the end of the process, we'll invite you to share feedback in a short survey - your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. We're excited to learn more about you and wish you the best of luck in the process! #RPOEMEA

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Required Skills:

 

 

Preferred Skills: