High-End Performing Senior Consultant with GMP IT & Automation experience from Pharma manufacturing

For company located in Aarhus, Workdenmark is looking for:

A High-End Performing Senior Consultant with GMP IT & Automation experience from Pharma manufacturing

Who We Are

You will be joining a team of compliance specialists (quality and regulatory issues) in current Good Laboratory Practice (cGLP), current Good Clinical Practice (cGCP), and in current Good Manufacturing Practice (cGMP) / current Good Automated Manufacturing Practice (cGAMP).

We have a strong senior experience in the regulated Life Science industry, where we offer our clients services within validation documentation, GAP analysis, project management, and medical writing (only for the ScienceOnDemand services).

Overall we ensure the client’s optimal quality processes, their inspection readiness, and hence we ensure their business performance.

We highly value a continuously focus on training and certification, so if you do not yet have the right quality mindset with the necessary compliance level, we will help you to achieve it. However, it would be a preferred pre-hand advantage.

Your Consultancy Assignments

Your consultancy assignments will primarily be project based with major duties and responsibilities within especially IT & Automation. Among others:

• Create, review, and approve compliance documentation
• Assist with compliance investigations as applicable
• Perform data analysis, identify corrective/preventive actions, and implement process improvements with a focus on quality processes
• Facilitate evaluations and compliance audits of manufacturing
• Ensure relevant operating procedures are followed in accordance with current instructions
• Provide input and decision making for the quality unit with regard to manufacturing and deviations
• Provide corrective actions as necessary
• Monitor assigned area for compliance to cGMP/cGAMP and Standard Operating Procedures (SOP) and equipment, processes, documentation, and personnel

Who You Are

You probably have a scientific background in:

BSc. / MSc. in Engineering (Process, IT, Machine, Electrical or similar)

Prior Experience

You probably have a minimum of 5-10 years of experience in a regulated environment:

• A solid experience in Life Science manufacturing
• Hands on experience within IT & Automation
• Hands on experience and competencies within writing test and qualification protocols, preferably also test execution and reporting
• Hands on experience of project management (use of project planning tools, financial planning etc.), i.e. demonstrated success supporting large and complex projects
• Successful experience leading and developing an effective team (client employees, alliances, regulatory authorities as well as other relevant project stakeholders)
• Experience working in complex and possibly cross border environments with multinational clients with different cultures

What We Offer

You will become a member of a team with a strong focus on team spirit, knowledge sharing, and hence a passion for continuous education, training and certification.

You will be offered a competitive pay package with a 13% employer paid pension scheme, including insurances, and additionally you will be joining a bonus arrangement.

You will have flexible working hours and location, however it should meet the client’s and colleague’s needs and expectations.

Please send your application and CV to: mbu@workindenmark.dk