GMP Compliance Specialist

This position has been filled.

GMP Compliance Specialist

For our client developing unique SCADA solutions, we are seeking a GMP Compliance Specialist with strong expertise in GxP and GAMP5. You will be part of a dedicated development team that creates and delivers automation and information solutions to industrial clients within the Life Science sector.

As a GMP Compliance Specialist, you will be responsible for communication both externally with clients and internally with colleagues regarding GxP and GAMP5. In this role, you will also be involved in projects where GxP or GAMP5 requirements are introduced early in the process when task specifications are outlined and again towards the end of the process when the project needs to be qualified and validated.

Furthermore, you will contribute to ensuring internal compliance by collaborating with Pharma Engineering colleagues in Ballerup and Hedensted.

With your experience, you will initiate and drive new quality and compliance projects, ensuring that the local QMS is updated with relevant GxP/GAMP5 regulations and tailored to the company’s QMS.

You will closely collaborate with stakeholders at the client’s company, and reporting to the Manager PMO, Compliance, and Electrical Services, you will have a fixed base at the company’s Pharma Engineering office in Ballerup.

Key tasks/success criteria:

• Internal and external consultation regarding GxP regulations (21CFR, ISPE GAMP5 guidelines)
• Execution of practical review/approval of deliveries for the validation of computer systems, as well as FAT/SAT and qualification
• Your technical expertise matches the customer’s within GxP, making you a valuable sparring partner
• Maintenance and ensuring updates of the company’s QMS
• Establishment of training for current and new employees Professional

Qualifications:

• You hold a degree in engineering, mechanical engineering, automation technology, process technology, or a similar field with experience in the biotech/pharma industry
• Alternatively, you may have a scientific background with experience in automation solutions
• Knowledge of Pharma Engineering is preferred
• Throughout your career, you have built a high level of technical expertise that matches the customer’s within GxP
• Familiarity with QMS systems, SCADA, and PLC is an advantage

Personal attributes:

• You have a strong drive and thrive in your field of expertise
• Achieving results is important to you
• Your approach is structured, analytical, and you handle multiple tasks simultaneously
• You are process-oriented with a strong quality mindset and a drive for results
• As a person, you possess strong communication and collaboration skills and have a high degree of personal integrity
• Additionally, you are dynamic, customer-focused, and work well in a multicultural environment
• Travel activity is approximately 30 days per year

Department description:

• The department consists of 55 employees
• The office is located in beautifully renovated premises in Ballerup, and the company is experiencing significant growth
• The company prioritizes a positive working environment, and everyone is always ready to help when needed
• The leadership style follows a typical Nordic philosophy in a modern and flat organization
• Mutual respect is valued, and there is trust in individual competencies and a high level of trust in individual judgment
• This requires independence and initiative, but in return, it provides you with a unique position in the market where you have a high level of trust and freedom
• Additionally, a versatile everyday work life is offered in collaboration with some of the most skilled technicians and engineers, where responsibility, quality, and innovation are highly valued.

If you are interested in learning more, feel free to contact Managing Partner Birgitte Dyreborg at mobile +45 2034 9707, and you can send your application to Head of Research Camilla Lykke Hansen at email: [email protected]