Senior Specialist It Compliance

14 hours ago

Nenagh, County Tipperary, Ireland Merck Gruppe - Msd Sharp & Dohme Full time

Job Description
An exciting opportunity to join the Ballydine site as a Senior Specialist in IT Compliance.
The successful candidate will be computerised systems validation lead for the site.
This role will be within the technical unit, ensuring adherence to policies/procedures and driving continuous improvement with a risk-based, lean approach to computerised systems compliance.
Key Responsibilities:
Lead/support site and cross-functional teams on computerized system validation and information technology and operational technology (IT/OT) compliance.
Support Computerized System Digital Validation System Development Lifecycle (SDLC), CSA, Inventory, Change, and Deviation Management.
Ensure compliance deliverables
Represent compliance during audits/inspections and develop audit responses.
Identify and remediate IT/OT compliance risks; support risk assessments for new tech or changes.
Support compliance operations in Automation and IT teams.
Assist local teams with quality/compliance challenges and SOP adherence.
Monitor deviations/CAPAs and communicate SDLC policy changes.
Collaborate with compliance groups and other sites to share best practices.
Skills & Experience:
Bachelor's in Computer Science, Engineering, Regulatory Compliance, or related.
5+ years in compliance support.
Strong knowledge of 21CFR Part 11, EMEA Annex 11, GAMP 5
Experience managing internal/external auditors.
Understanding of Pharmaceutical Manufacturing, Quality, and Supply Chain processes.
Strong stakeholder management and communication skills.
Strategic thinker, results-driven, self-motivated leader.
Expertise in Computer Systems Validation, Instrumentation/Automation, Project Management.
Experience with real-time shopfloor/lab systems integration.
Exposure to diverse technologies and business process re-engineering.
Lean Six Sigma Green Belt is an advantage.
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:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Required Skills:
Audit Management, Business, Governance Management, IS Audit, Management Process, Quality Assurance (QA), Quality Management, Risk Management, Technical Advice
Preferred Skills:
Job Posting End Date:
09/5/2025
*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:
R361615
#J-18808-Ljbffr

  • Safety and Compliance Specialist

    2 days ago

    Nenagh, County Tipperary, Ireland beBeeHealth Full time €55,000 - €60,000

    Job Overview:We are seeking a Safety and Compliance Specialist to lead the development of a proactive health and safety culture across our site. As a key member of our team, you will be responsible for staying informed of new legislation and industry developments, maintaining a working knowledge of current practices, and conducting regular internal audits to...

  • Senior Qa Specialist

    4 days ago

    Nenagh, County Tipperary, Ireland Headcount Solutions Full time

    Senior QA Specialist As a Senior QA Specialist, you will be a key driver of quality assurance activities on the site of a leading Tipperary based Pharmaceutical multinational, ensuring that all operations align with c GMP principles and regulatory expectations from agencies such as the FDA and EMEA.You will take ownership of maintaining compliance within...

  • Senior QA Specialist

    5 days ago

    Nenagh, County Tipperary, Ireland Scientificjobs Full time

    Senior QA Specialist (hybrid)RK2376211 MonthsTipperary We're currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Tipperary. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.As a Senior QA Specialist, you will be a key driver...

  • Senior Quality Assurance Specialist

    5 days ago

    Nenagh, County Tipperary, Ireland beBeeQuality Full time €60,000 - €100,000

    Job Title: Senior Quality Assurance SpecialistA senior quality assurance specialist plays a critical role in ensuring that all operations align with good manufacturing practice (GMP) principles and regulatory expectations from agencies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).Key Responsibilities:Lead the...

  • Senior QA Specialist

    7 days ago

    Nenagh, County Tipperary, Ireland Tandem Project Management Limited Full time

    Summary: A Senior QA Specialist is required for a pharmaceutical company in South Tipperary. The successful candidate will ensure that all operations align with cGMP principles and regulatory expectations from agencies such as the FDA and EMEA. Onsite attendance is required during the training period. After training, the position offers one day of remote...

  • Senior Qa Specialist

    5 days ago

    Nenagh, County Tipperary, Ireland Tandem Project Management Limited Full time

    Summary: A Senior QA Specialist is required for a pharmaceutical company in South Tipperary.The successful candidate will ensure that all operations align with c GMP principles and regulatory expectations from agencies such as the FDA and EMEA.Onsite attendance is required during the training period.After training, the position offers one day of remote...

  • Senior Qa Specialist

    4 days ago

    Nenagh, County Tipperary, Ireland Tandem Project Management Limited Full time

    Summary: A Senior QA Specialist is required for a pharmaceutical company in South Tipperary.The successful candidate will ensure that all operations align with cGMP principles and regulatory expectations from agencies such as the FDA and EMEA.Onsite attendance is required during the training period.After training, the position offers one day of remote...

  • Senior Specialist

    1 week ago

    Nenagh, County Tipperary, Ireland Msd Malaysia Full time

    Senior Specialist - Cleaning SME page is loadedSenior Specialist - Cleaning SMEApply remote type Hybrid locations IRL - Tipperary - Ballydine time type Full time posted on Posted 7 Days Ago time left to apply End Date: August 27, days left to apply) job requisition id R361474Job DescriptionA fantastic opportunity has arisen for aSenior Specialist - Cleaning...

  • Senior Culinary Specialist

    5 days ago

    Nenagh, County Tipperary, Ireland beBeeCulinary Full time €36,000 - €48,000

    Senior Culinary Specialist Job DescriptionWe are seeking an accomplished Senior Culinary Specialist to contribute their expertise in culinary skills and effective menu management to our kitchen team.Key Responsibilities:Prepare and cook high-quality dishes using fresh Irish ingredients, adhering to exceptional food safety standardsCollaborate with the...

  • Senior Automation Specialist

    3 days ago

    Nenagh, County Tipperary, Ireland beBeeAutomation Full time €72,000 - €96,000

    Job Title: Senior Automation Specialist">The ideal candidate for this role will have a strong background in automation engineering, with experience in the medical device sector or other regulated manufacturing environments. This is an exciting opportunity to join a global leader in the industry and contribute to the development of cutting-edge automation...