Compliance Specialist

Compliance Specialist

Location: Leiden

Duration: 12 months

Hours: Full time, 40 hours per week

Imagine your next project as a Compliance Specialist, working at the forefront of cutting edge work and technology with one of the leading Pharmaceutical companies in the world!

roles and responsibilities

Within the Advanced Therapies Pilot Plant Operations (ATPO) team, this role typically includes:

• Coordinates processes for the ATPO department aligned with key quality performance measures, company standards, and high-level goals and objectives.

• Follows Annex 1 guidance

• Supports and assists with GMP compliance processes, including implementation of quality goals, cross-functional collaboration, and creation of documentation that meets regulatory requirements.

• Applies functional knowledge of GMP compliance standards; gathers, collects, and disseminates feedback to drive continuous improvement and best practices across the organization.

• Carries out and maintains standard operating procedures for documentation collection, storage, and dissemination.

• Analyzes research and data related to regulatory changes, external trends, and strategy.

• Executes nonconformances, CAPAs, corrections, and ensures changes are implemented with Change Control if required.

• Coordinates, reviews, coaches, and trains employees performing investigations; authors, coordinates, and reviews documentation.

• Assures compliance levels are maintained, supports audits, flags compliance issues, and ensures follow-up with QA.

• Participates as a team member in projects and compliance-associated tasks (e.g., pre-audit trainings, GEMBA, self-inspection follow up).

• Recommends and develops improvements to processes and procedures.

• Performs related duties as assigned by supervisor and maintains compliance with all company policies and procedures

how to succeed

• Minimally Bachelor’s degree in Science, Engineering and Technical subjects.

• At least 2 years’ experience in the biotechnology or biopharmaceutical industry in required.

• A good understanding of GMP / Annex 1 regulations is required

• Good English verbal and written communication skills (Dutch preferred), including ability to effectively communicate with internal and external stakeholders.

• Excellent computer proficiency e.g. MS Office.

• Excellent analytical skill to identify gaps and root causes of issues and think out of the box to develop a solution.

• Must be able to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude.

details

This role offers a very competitive hourly rate. This contract will run for a 12 month duration. This is an on-site position.

you are welcome here

Johnson & Johnson is 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.

about Johnson & Johnson

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson. 

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. 

questions

If you would like some additional information about the role please contact: simone.strong@randstadsourceright.co.uk

Diversity, Equity & Inclusion

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 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”.