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Location

Lazio | Italy

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Job description

Job Description - Product Quality Specialist - Stability (2406172330W)

Product Quality Specialist - Stability - 2406172330W

Description

Johnson & Johnson's Family of Companies is recruiting for a Product Quality Specialist, in the Product Quality Management Stability Center of Excellence.

At Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We collaborate with the world for the health of everyone in it.

The Product Quality Specialist, Stability CoE, has end-to-end accountability for the stability management and oversight from Late Stage Development through full commercialization lifecycle for a portfolio of products. Responsibility for product quality related activities with a specific expertise in stability including protocol and report generation. Supporting the work of PQI/PQO and actively contributing to overall smooth functioning of the Stability CoE.

As a Product Quality Specialist, your main responsibilities include but are not limited to:

• Stability POC for a set of products families (API and Drug Product)
• Oversight of Sample management for stability
• Author/oversight of stability Protocols and Reports in accordance with global SOPs including sampling strategy.
• Support audits and filings as appropriate related to stability questions.
• Responsible for stability Lifecycle management
• Supports PQI/PQO and Business Partners with stability related questions.
• Support temperature excursions, change controls, stability notifications and escalations as applicable.
• Maintain stability statements for assigned products.
• Partner with Stability Labs as needed to ensure questions are addressed in a timely manner.
• Active Member of Stability CoE:
• Give input on topics raised in staff meetings to support continued improvement of stability processes.

Qualifications

• Bachelor’s degree with a major in Pharmacy, Chemistry, Biology, Biochemistry, Engineering, or a similar technical/scientific degree is required.
• A minimum of 6 years of relevant experience is required
• A minimum of 4 years’ experience in the pharmaceutical, biotechnology, or medical device industry is required (post graduate experience and/or education will count towards years of industry experience).
• Experience in API and drug product stability and business implications regarding stability decisions is desired.
• Understanding of quality processes/systems (e.g. change control, event handling, CAPA), risk management is required.
• Insight in pharmaceutical and/or chemical processes, product quality assurance/control, and product development and manufacturing is a plus.
• Demonstrated ability to work independently and in a team environment
• Relationship building as part of a team is required.
• Strong written and oral communication skills with various levels of the organization.
• Understanding of global regulatory requirements and guidelines applicable to pharmaceuticals, with the ability to apply GMP regulations.
• Must be flexible to accommodate US, EMEA and AP work schedules when vital, balancing work and personal time
• This position may require up to 5-10% domestic and international travel as business demands.

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!

Primary Location

Primary Location

Europe/Middle East/Africa-Netherlands-South Holland-Leiden

Other Locations

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive considerationfor employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin,or protected veteran status and will not be discriminated against on the basis of disability.andEqual Employment Opportunity Posters GINA Supplement.

If you are an individual with a disability, please check ourpage for information on how to request an accommodation.Disability Assistance

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