Spclst, Quality Assurance

Job Description

An amazing opportunity has arisen for a Quality Systems Specialist to join our team at our Dunboyne facility.

The successful candidate will be responsible for maintenance and continuous improvement of the Quality Management System (QMS). The Quality Systems Specialist will play a crucial role in ensuring compliance with regulatory requirements and driving continuous improvement in our quality systems.

The main areas of focus for this role are SAP Quality Master Data build and maintenance and site change control oversight. The QA Systems Team works closely with the Operations, MS&T, Engineering, Validation, Supply Chain and QC/Analytical functions to ensure compliance to Global and Regulatory Quality Management System requirements as they pertain to our Company Quality Manual.

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

• Support site teams in Change Control Management including training, role certification and system access.
• SME for Change Control EDMS and supporting business systems
• Support creation and maintenance of Quality Master Data including Inspection Plans, CoA generation, BRR checklists, expiry/storage, TOCS.
• Support BOM build and ongoing maintenance.
• Support creation, maintenance and continuous improvement of Quality Management Systems (QMS) and associated documentation.
• Create and maintain assigned SOPs.
• Participate daily on cross-functional teams collaboratively and actively to address compliance issues and achieve project milestones.
• Participate in QMS Communities of Practice and support an environment of continuous improvement by identifying and implementing efficiencies and quality improvements.
• Drive change control quality metrics for the site and provide inputs to site and OpU Quality Council.
• Support Regulatory and Compliance Inspections at the site, as required.
• Support the wider quality team in areas of supplier quality management, quality agreements, new product introduction, documentation management, Deviation management and complaint management.
• Ensure the health & well-being of the Quality Management system at the site to ensure timely actions are taken to meet compliance & production needs.
• Comply with our Global and regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
• Drive continuous improvement and participate in initiatives to enhance operational efficiency and resolve issues.

What skills you will need:

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

• Minimum degree or post-graduate qualification (Science/ Pharmacy/ Engineering). At least 3 years’ experience in the pharmaceutical industry (preferably experience in Biologics)
• Understanding and practical application of GMP standards and regulations Working knowledge of QMS regulations and best practices
• Desire to continuously learn, improve and develop.
• Analytical problem-solving skills.
• Experience supporting Change Management Systems.
• Strong knowledge in SAP ECC usage, quality master data an advantage. 
• Strong attention to detail and precision in preparing and reviewing GMP documentation.
• Previous experience in quality management systems such as Veeva, Delta-V, PAS-X, MES, DSP etc. or similar.

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.

So, if you are ready to:

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

Required Skills:

Preferred Skills:

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. 

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Relocation:

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