Quality Specialist

3 days ago

Carlow, Ireland MSD Full time

Job Description

The QA (Quality Systems and Compliance) Specialist at our Carlow Site will ensure compliance of vaccine and biologics manufacturing processes with cGMP and regulatory requirements. This role involves providing cross-functional support, facilitating compliance, and supporting quality systems, monitoring, and management. Ideal candidates will have 3-5 years of pharmaceutical/regulatory experience and a strong working knowledge of aseptic processing and environmental monitoring in a sterile manufacturing facility. The role also includes liaising with technical experts from other sites and providing technical expertise and training in various operational areas.

What you will do:

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

  • Ensure compliance with cGMP and regulatory requirements for vaccine and biologics manufacturing processes
  • Act as site lead for nominated quality systems and support their continuous improvement
  • Participate in Plant/Quality committees and collaborate with other site functional groups
  • Provide support and advice cross-functionally on day-to-day and project basis
  • Develop and implement improved quality reporting measures
  • Liaise with technical subject matter experts from other company sites
  • Initiate and maintain quality-related metrics and drive change in quality systems

What skills you will need:

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

  • 3-5 years of experience in pharmaceutical/regulatory environment
  • Bachelor's degree in a related Science discipline
  • Strong working knowledge of aseptic processing and sterile manufacturing
  • Proficiency in EU/US quality-related pharmaceutical regulations
  • Knowledge of regulatory/code requirements and industry best practices for quality and compliance
  • Experience with Lean Six Sigma Methodology preferred
  • Strong verbal and written communication skills, project management skills
  • Proficiency in Microsoft Office and job-related computer applications
  • Decision-making capability, problem-solving skills, and collaboration 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 hybrid working model for office-based colleagues around the world.

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:

Regular

Relocation:

Domestic/International

VISA Sponsorship:

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

10/1/2024

*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.


Job Posting End Date:10/01/2024


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.


Requisition ID:R311121

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