QA Specialist Pharma Complaints, fixed-term (1 year)

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Learn more at 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 QA Specialist - Pharma Complaintsfixed-term in Schaffhausen Switzerland.

Purpose:

In this role you will investigate product quality concerns based on customer complaints and ensure that all complaintrelated activities are conducted in a compliant structured and timely manner. You will collaborate with crossfunctional experts to perform root cause analysis assess risks and contribute to continuous improvement activities across the site.

You will be responsible for:

• Investigating product quality concerns based on customer complaints.

• Assessing coordinating and/or conducting assigned customer complaint investigations.

• Inspecting returned products analyzing technical details performing root cause analysis and risk assessments and assisting or leading associated CAPA investigations.

• Ensuring accurate documentation and closure of each complaint to support sound regulatory reporting decisions.

• Developing a detailed understanding of the products and previously investigated complaints.

• Evaluating the market impact of new complaints and escalating critical issues requiring immediate action.

• Reviewing and analyzing complaint information for trending risk analysis corrective actions and evaluating the effectiveness of implemented measures.

• Supporting internal external and thirdparty audits.

• Participating in additional project activities investigations and process improvement initiatives.

Qualifications / Requirements:

• Masters degree PhD or equivalent experience in engineering physical biological or natural sciences is required.

• Strong written and verbal communication skills in English.

• Investigative analytical and critical thinking skills.

• Strong decisionmaking abilities including sound judgment with limited information.

• Minimum 1 year of experience in quality within pharma/medical device or other regulated industries is preferred but not required.

• Knowledge of statistical applications and auditing practices is preferred but not required.

This is a fixed-term position for 1 year.

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.

Heres what you can expect:

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

• Getting to know you:If theres a good match youll 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 well 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. Were excited to learn more about you and wish you the best of luck in the process! #RPOEMEA

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