MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
MSD Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
MSD Carlow offers a new opportunity to join the quality team.
The Quality Assurance Specialist role supports the introduction and execution of new products, materials and drug substance into the Carlow facility.
The QA Specialist (NPI / DS / Materials) will participate as a core member of the Technical Transfer Team that manages Vaccine and Biological product development and manufacture, along with day to day QA activities, including:
1. Ensuring that the process for the introduction of biologics/vaccines is in compliance with cGMP and the associated regulatory requirements.
2. Reviewing and approving documentation to support corporate compliance/regulatory expectations for manufacturing.
The role reports to the Associate Dirctor of Quality and who will liaise with cross functional teams on site, in particular Supply Chain, Technical Engineering and Operations to ensure manufacturing, technical and regulatory requiements are met.
The ideal candidate will have approximately 3-5 years experience in a quality based role in a pharmaceutical company.
- Provide quality oversight and direction for the introduction of new products, drug substance and materials onto site covering the end to end strategy.
- Quality point of contact at both a site level and for all external inputs (Transfer Site QA/QC/ Regulatory), including co-ordination of/attendance at Quality working group meetings.
- Participate as functional expert in the cross functional team that manages introduction of products and materials at MSD Carlow.
- Performs quality reviews and approvals of engineering/validation/automation/utilities commissioning and qualification activities.
- Authors, reviews and participates in approvals of protocols and reports for technology transfer, method qualifications and method validation.
- Review other documentation associated with new product, drug substance and material introduction (Material Packs, QC Test Specifications, BOMs, MES documentation etc.)
- Provide quality oversight and direction for Material introduction process and external party management.
- Development & monitoring of supplier performance metrics. Actively participates as a member of Material Review Board and Quarterly Business Review of key suppliers, and other cross functional forums as requested.
- Maintain the approved supplier management list within the qualified Supplier Management system by ensuring that all suppliers and materials used at Carlow are correctly set up.
- Responsible for supporting deviation and atypical close out and initiating/following up on corrective and preventative actions.
- Facilitate compliance direction for the site by assisting in the adherence to divisional policies and guidelines as well as regulatory requirements. Assist in the proactive evaluation of site compliance against emerging regulatory trends. Identify and facilitate major compliance initiatives to improve compliance status and overall operational efficiency of the site. Actively participate in Plant/Quality committees and works with other site functional groups, such as the QC, Production, Utilities, Site Services, and Maintenance to help set direction for plant wide GMP initiatives.
- Bachelors Degree or higher preferred; ideally in a related Science discipline
- P2 – Relevant experience and a particular skill set in their area of expertise that adds value to the business; ideally in a pharmaceutical manufacturing environments.
- Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
- Knowledge of cGMP and GDP preferred
- Report, standards, policy writing skills required
- Equipment and process validation
- Sterile filling processes and equipment
- Proficiency in Microsoft Office and job related computer applications required
- Lean Six Sigma Methodology experience desired
Initial Travel Requirements:
- Only very occasional travel may be required.
Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.