Product quality control specialist

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At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal. Through our expertise in Innovative Medicine and Med Tech, 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.

Job Function Quality Job Sub Function

Quality Assurance Job Category Professional All Job Posting Locations Beerse, Antwerp, Belgium, Latina, Italy, Leiden, South Holland, Netherlands, Little Island, Cork, Ireland We are searching for the best talent for a Product Quality Specialist.

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. Learn more at Purpose The Product Quality Specialist, Stability Co E, 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.

You Will Be Responsible For

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. Qualifications/Requirements 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.





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.

Required Skills Preferred Skills Business Alignment, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Human-Centered Design, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards Benefits The anticipated base pay range for this position is In addition to base pay, we offer the following benefits*: an annual premio with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans.

For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers. Amounts and actual benefits may vary by location and are subject to change. #

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7fqwwu