IT Quality, Validation, and Compliance Consultant

Pharma IT is searching for a Quality, Validation and Compliance Consultant to support our customers in validation and compliance work within the Pharma, Biotech, and Medical Device Industries.

Depending on your experience level and the complexity of the project, you will either work alone or under the guidance of a more experienced Compliance Manager. Consequently, functions can also include support to Senior Compliance Managers, as well as coordination and communication for validation activities.

This position presents large opportunities for growth, as you will be given greater responsibility over time.

For this role, it is essential that you have knowledge and experience from projects that use the V-Model and GxP. System validations will span from pure IT to laboratory equipment and pharmaceutical production equipment. Furthermore, the job is expected to be executed in accordance with internal and international guidance such as GAMP.

Key Job functions: Coordination, Quality Control, Reports, and Reviews

As a IT Quality, Validation and Compliance Manager you are expected to:

• Validate Computer Systems/Software Validation Procedures to ensure current regulatory compliance is met
• Identify and mitigate risks
• Prepare and execute validation protocols and reports
• Provide IT support and assessment for relevant quality deviations
• Recommend and manage corrective and preventive actions (CAPAs) to improve IT compliance
• Author SOPs and Work Instructions compliance of IT systems
• Ensure that proper CSV procedures are followed during system implementations and provide CSV support for new IT projects throughout the project lifecycle

Your background and experience

To be successful in the role of Quality, Validation and Compliance Manager, you will be expected to have:

• A bachelor’s degree or higher
• A minimum of 3-5 years of experience within the Pharmaceutical, Biotech or Medical Device Industries, as well as experience with test and validation
• An attentive and detail-oriented approach, as well as the ability to independently resolve a variety of issues without close supervision
• Good organizational and planning skills
• The ability to work collaboratively and as part of a team
• Excellent English communication skills (verbal, written, and interpersonal)

About Our Firm

Pharma IT aims to deliver price-competitive young talent and experienced professional IT consultants to the pharma, biotech, and medical device industries. Our exclusive focus on these industries and agile, customer-oriented approach ensures we maximize customer value. We assist clients across all key areas of these industries, including: Management & Business Consulting, IT Consulting, Drug Development, Medical Device Consulting, Manufacturing Consulting, Quality, Compliance & Security Consulting.

Our team consists of ~140 diverse and talented consultants, and we are currently experiencing rapid growth. We encourage people of all ages, genders, sexual orientations, nationalities, religions, and ethnic backgrounds, to apply. If you want to know more about us, feel free to check out our website at pharmait.dk

Benefits

Pharma IT offers industry-leading contracts and work-life balance. We offer a base salary with an accelerated bonus model as part of what we believe is one of the best employment packages in the industry. Our core belief is that employees should have flexible hours, do what they are best at, and be able to spend as much time at our customers’ sites as possible.

How to Apply

This position will be filled on a rolling basis. Interested applicants should apply by sending a CV and Cover Letter to info@pharmait.dk, with the subject line “IT Quality, Validation, and Compliance Consultant”.

If you have any questions about this role, feel free to reach out to the hiring manager for this position, Peter-Emil Iversen, at peei@pharmait.dk