Description
Johnson & Johnson is currently seeking a Sr. GMP Specialist to join our Bioprocessing Services Center of Expertise located in Leiden, the Netherlands.
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 https://www.jnj.com/.
Are you interested in a role where you can lead and implement improvements in cGMP processes across departments? Do you have experience in managing compliance activities such as audits and training within a production environment? Are you familiar with Lean techniques and concepts? If so, this could be the perfect opportunity for you!
What you will be doing:
The Sr. GMP Specialist facilitates cGMP as applicable to production. He/she is the primary contact for Operations regarding cGMP-related activities such as the deviation and change control process, audits, evaluations, trend reports, cGMP compliance, and training within Operations. He/she must build a strong network within the company; is involved in GMP-related projects, business innovation initiatives, and adjustments and optimization of the deviation and change control process.
What impact you will also have:
- Responsible for general processes such as gowning, routing, segregation, and floor plans/drawings. Keeping these processes up to date and implementing improvements is included.
- Identify improvements in cGMP related to cross-departmental issues and leads the team that implements these improvements.
- Lead cross-departmental changes and is aware of best practices within the JSC network.
- Act as an SME during external inspections and is capable of clearly explaining compliance issues.
- Provide support during internal audits regarding cGMP matters.
- Responsible for organizing external inspections within operations and facilitates, together with QA Compliance, the staffing of the inspection teams. This includes: - Arranging sufficient support or assisting with inspections.
- Informing Operations about upcoming and ongoing inspections.
- Facilitating timely responses to questions and observations.
- Correctly assessing off-site observations within the JSC network.
CGMP, EHS&S, LEAN EN PROCESS EXCELLENCE
The work is carried out under cGMP conditions. The role holder ensures a safe, healthy, and sustainable work environment. The execution of tasks, the organization of work, and the continuous improvement of efficiency, effectiveness, quality, and cGMP and EHS&S compliance are supported by Lean techniques and concepts.
The role holder has good knowledge of cGMP, EHS&S, and Lean, trained in internal procedures, and follows them at all times. The role holder identifies shortcomings and opportunities for improvement and independently implements improvement initiatives with support from other departments.
Qualifications
We would love to hear from you, if you have the following essential requirements:
- Minimum HBO relevant education.
- Minimum 5 years of experience.
- Familiarity with the cGMP requirements for both clinical and commercial manufacturing.
- Able to continuously see improvements in (work) processes and implement them.
- Sets the right priorities, when needed in close coordination with involved parties.
- Aims for a thorough and flawless introduction in the execution of core tasks and for sustainable and stable solutions that meet the needs of the customer/user.
- Investigates the cause of problems and makes good use of data. Identifies ideas and actions aimed at structural solutions.
- Can manage content teams within the operations department.
- Capable of making well-founded decisions within set frameworks.
What type of mark will YOU make?
By joining Johnson & Johnson you will find boundless opportunities to craft your path & amplify your impact inside & outside our walls. And with our commitment to be the world’s healthiest workforce you can strengthen your body as well and your mind. When you work at Johnson & Johnson you can touch over a Billion lives worldwide every day. And when you apply your talent to our collective purpose there’s no end to the lasting impact we can make together. And that changes everything.
Diversity, Equity & Inclusion at Johnson & Johnson means "YOU belong"!
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong!