Senior Quality Specialist

Experic Kilbeggan, County Westmeath, Ireland
Senior Quality Specialist
Experic Kilbeggan, County Westmeath, Ireland
Direct message the job poster from Experic
Position:
Senior Quality Specialist-Qualification & Validation
Department:
Quality Assurance
Reports To:
Associate Director of Regulatory Quality
Classification:
Full time-On site
FLSA Status:
Exempt
SUMMARY/OBJECTIVE:
The Senior Quality Specialist– Qualification & Validation is responsible for ensuring compliance with regulatory requirements, industry standards, and company policies related to qualification, validation, and quality assurance in a pharmaceutical manufacturing environment.
This role involves leading validation activities for equipment, facilities, utilities, cleaning processes, and computerized systems to maintain the highest standards of product quality and regulatory compliance.
Additionally, the role requires expertise in managing a Quality Management System (QMS), writing Standard Operating Procedures (SOPs) and work instructions, and conducting root cause analysis and risk assessments to improve compliance and operational efficiency.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Ensure compliance with GMP (Good Manufacturing Practices), FDA, EMA, ICH, and other global regulatory guidelines.
Develop, implement, and oversee quality systems related to validation, qualification, and change control.
Serve as the primary QA contact for validation activities, ensuring proper documentation, execution, and review of validation protocols.
Conduct internal audits and regulatory inspections to assess compliance with quality and validation requirements.
Ensure that validation deviations, non-conformances, and CAPAs (Corrective and Preventive Actions) are effectively investigated and closed.
Oversee and manage the Quality Management System (QMS), ensuring compliance with regulatory and company standards.
Develop, review, and maintain SOPs, work instructions, and other controlled documents related to quality and validation.
Support secondary packaging and labeling activities and other specific client requirements
VALIDATION &QUALIFICATIONS MANAGEMENT:
Lead the development and execution of IQ/OQ/PQ protocols for equipment, utilities, facilities, and computerized systems.
Oversee process validation, cleaning validation, method validation, and continued process verification.
Collaborate with other functional areas to ensure proper qualification of new and existing equipment.
Establish validation master plans (VMPs) and maintain validation lifecycle management.
Conduct risk assessments for validation and qualification activities using FMEA and other risk management tools.
Leadership & Cross-Functional Collaboration:
Provide technical leadership and mentorship to QA, validation, and production teams.
Serve as a liaison between Quality, Manufacturing, Engineering, and Regulatory Affairs as required to ensure alignment on validation strategies.
Train and educate staff on validation principles, regulatory expectations, and quality systems.
Support change control processes to ensure validation compliance when implementing new systems or modifying existing processes.
Documentation & Data Integrity:
Ensure accurate and complete documentation in compliance with Good Documentation Practices (GDP).
Review and approve validation protocols, summary reports, and technical documents.
Maintain data integrity standards and ensure compliance with 21 CFR Part 11 and Annex 11 for computerized system validation.
Write, review, and update SOPs and work instructions to ensure clear and compliant operational procedures.
Conduct root cause analysis (RCA) for deviations, non-conformances, and validation failures to implement effective corrective actions.
Perform risk assessments and apply risk management tools (e.g., FMEA, HACCP) to proactively identify and mitigate potential quality and compliance risks.
Lead CAPA investigations and track implementation of preventive measures to enhance operational quality and regulatory compliance.
Qualifications & Experience:
Education
: Bachelor's or Master's degree in Pharmaceutical Sciences, Engineering, Chemistry, Biology, or a related field.
Experience
: Minimum of 4-8 years of experience in pharmaceutical or biotech manufacturing with a strong focus on validation, qualification, and quality management.
Equipment, facility, and utility qualification (HVAC, Fridges and Freezers and temperature controlled storage areas etc.)..
Computerized system validation (CSV) and data integrity compliance.
GMP compliance, risk-based validation approaches, and regulatory audits.
Managing QMS, writing and maintaining SOPs and work instructions.
Performing root cause analysis, risk management, and CAPA investigations.
Technical Skills
: Proficiency in FDA, EMA, ICH Q7-Q10, ISO 9001, and EU GMP Annex 11 and 15 validation requirements.
Soft Skills
: Strong leadership, communication, problem-solving, and project management skill
Must be able to work in a fast-paced, highly regulated manufacturing environment.
SUPERVISORY RESPONSIBILITIES:
None
WORK ENVIRONMENT:
Standard Office Environment (standing and sitting) requiring minimal physical exertion.
PHYSICAL DEMANDS:
Office Environment (standing and sitting) requiring minimal physical exertion.
TRAVEL:
This role requires periodic travel for regulatory inspections, supplier audits, and external validation activities.
Seniority level
Seniority level
Associate
Employment type
Employment type
Full-time
Job function
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Experic by 2x
Get notified about new Quality Specialist jobs in
Kilbeggan, County Westmeath, Ireland
.
Senior Specialist, Quality Assurance- Drug Product(12 months fixed term)
Product Release & Compliance QA Specialist
Tullamore, County Offaly, Ireland 6 days ago
Senior Quality Systems Engineer (m/f/x)*
Senior Software Quality Systems Engineer
Fluid Management Field Application Specialist - Remote - Boston, MA
Rhode, County Offaly, Ireland 2 weeks ago
Field Application Specialist - Bioprocessing - Chromatography - Remote - Boston, MA
MRHT Clinical Nurse Specialist – Diabetes
Tullamore, County Offaly, Ireland 1 day ago
Moategranoge, County Westmeath, Ireland 3 weeks ago
MRHP Clinical Midwife Specialist - Bereavement & Loss
Portlaoise, County Laois, Ireland 1 day ago
MRHT Clinical Nurse Specialist (Acute Haematology Oncology)
Tullamore, County Offaly, Ireland 1 week ago
Commercial Manager - Collinstown
We're unlocking community knowledge in a new way.
Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr