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 for a Quality Control Systems Specialist to join the quality team.
The QC systems specialist role will provide in-line technical support in relation to Laboratory Systems such as LIMS, Empower, SAP, instrument software and Data Integrity to ensure the continued manufacture and supply of quality pharmaceutical products meeting our Manufacturing Division priorities of: Compliance, Supply, Strategy and Profit Plan. Ensure that objectives are effectively achieved, consistent with MSD's requirements to ensure compliance, safety and reliable supply to our customers
The Laboratory Systems specialist role acts as LIMS Site Administrator, Empower administrator and SAP (QM) master data maintainer for the site Laboratories and is required to be a subject matter expert in these areas. The role supports all internal customers including QC, QA, Automation and Operations . The role also supports external customers when required such as other MSD sites and Global functions. A high level of self-motivation, knowledge, enthusiasm and drive is required.
- Provide efficient support to all departments at MSD Carlow including QC Microbiology, Quality Control and IPT for issues pertaining to LIMS, Empower and SAP, and to be a subject matter expert for these systems.
- Deliver systems training to new hires and as additional roles are required for existing personnel.
- Development and testing of systems master data. Perform new master data builds for the introduction of new products in line with analytical change control requirements to ensure the functionality is available in line with site schedule requirements.
- Provide technical support to all users at MSD Carlow. Liaise with Global systems working groups.
- Provide subject matter expertise in relation to Laboratory Systems. Works on improvement projects in relation to LIMS and other laboratory systems as required.
- Actively identifies and progresses continuous improvement opportunities. Ensures strict adherence to site policies/procedure and good manufacturing practices.
- Coach and guide colleagues onsite and in the network on the use of Laboratory Systems
- Leadership activities including selection, development, coaching and day to day management. Ensure that the team receives appropriate resources and programmes to develop technical and other skills, to complete their jobs whilst stimulating personal growth and development in line with role. Develop and maintain training programmes.
- Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
- Performs assessments and provides overview of systems from a data integrity perspective ensuring the highest standards are maintained.
- Work collaboratively to drive a safe and compliant culture in Carlow.
- Lead Laboratory Projects for the Lab systems team.
- May be required to perform other duties as assigned.
- Bachelors Degree or higher preferred; ideally in Science/IT or a closely related discipline
- Considerable experience and critical skills in the area of expertise that add value to the business; ideally in Laboratory Systems setting. Preferably LIMS, Empower and SAP.
- Knowledge of data integrity requirements required.
- Change Management Skills (CEM) with continuous improvements.
- Knowledge of cGMP and GDP preferred
- Proficiency in Microsoft Office and job related computer applications required
- Lean Six Sigma Methodology experience desired
Initial Travel Requirements:
- 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.
Search Firm Representatives Please Read Carefully:
MSD is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at MSD via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of MSD. No fee will be paid in the event the candidate is hired by MSD as a result of the referral or through other means.