Quality & Data Integrity Risk Management Specialist

Job Description

An amazing opportunity has arisen for a Quality & Data Integrity Risk Management Specialist. This role will be responsible for supporting the Quality & Data Integrity Risk Management Program for areas within the remit of Our Company’s our Manufacturing Division Quality organization at Dunboyne Biologics.

What you will do:

Bring energy, knowledge, innovation, and leadership to carry out the following:

• Support integration of a harmonized global risk management program into Site Quality Management System.
• Support integration of Quality Risk Management as it relates to data governance and GMP records.
• Support execution of risk assessments, risk control, risk communication and risk review.
• Support maintenance of site risk register.
• Provide risk management & data integrity training on site as required.
• Support the Site Quality Risk Management Council governance process.
• Represent organisation at Industry forums.
• Support DI GEMBA program within site.
• Support investigations from a QRM and DI perspective as required.
• Support Inspection Readiness, Hosting & Response activities as required.

Qualifications

In order to excel in this role, you will more than likely have:

• Minimum degree or post-graduate qualification (Science/ Pharmacy/ Engineering).
• 5 years’ experience in the pharmaceutical or biologics industry.
• Understanding and practical application of GMP standards and regulations.
• Strong working knowledge of laboratory, manufacturing and supporting computerised systems, and associated business processes.
• Proven record of influencing change.
• Skilled supporting cross-functional investigations.
• Analytical problem-solving skills.

As a company, we are committed to 'Inventing for Life' in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about our hybrid working model

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, please apply today.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.