Product Quality Specialist K857Pubblicato il 21-11-2020 - Johnson & Johnson Family of Companies in Latina Provincia
Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a Product Quality Specialist, in the Product Quality Management Stability Center of Excellence.
At the Janssen Pharmaceutical Companies of 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 are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal.
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 small molecule products. Responsibility for product quality related activities with a specific expertise in stability including protocol and report generation. Supporting the work of PQI/PQO/PQL 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:
- PQS 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 filing as appropriate related to stability questions
- Responsible for stability Lifecycle management
- Supports PQI/PQL/PQO and Business Partners with stability related questions, as applicable
- 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 regarding protocols is addressed in a timely manner.
- Active Member of Stability CoE:
- Support departmental goals.
- Give input topics raised in staff meetings to support continued improvement of stability processes.
- Identify opportunities for improvement based on product work.
- Bachelor’s degree with a major in Pharmacy, Chemistry, Biology, Biochemistry, Engineering, or a similar technical/scientific degree is required.
- A minimum of 4 years of relevant experience is required
- A minimum of 2 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.
- Understanding of global regulatory requirements and guidelines applicable to pharmaceuticals, with the ability to apply GMP regulations is an asset
- 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.
- Must be flexible to accommodate US, EMEA and AP work schedules when vital, balancing work and personal time
- This position may require up to 10% domestic and international travel as business demands.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for 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.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
United States-New Jersey-Titusville-1125 Trenton Harbourton Road
JANSSEN SUPPLY GROUP, LLC (6046)