QA Senior Specialist

About the Company:

Innopharma Technical Services, part of Innopharma Group, specialise in the
training and provision of highly skilled, project ready, Contract Engineers & Scientists to the (Bio)
Pharmaceutical and MedTech Manufacturing Sector.

Location: co. Louth

Are you ready to take the next step in your career within a leading biopharma environment?

We are now seeking QA Senior Specialist to provide support to our multinational pharmaceutical client
site based in Co.Louth.

About the position:

A QA Senior Specialist (CSQ/CQV specialist) will be reporting to the QA CSQ/CQV Lead.
This role is responsible for oversight of all validation activities ensuring compliance with current
regulatory requirements, cGMP and company SOPs. It includes validation/qualification activities for
facilities, utilities, equipment, computerized systems, cleaning, processes, storage areas, controlled
temperature units (CTUs) and shipping. Provision of QA oversight to the Commissioning, Qualification
and Validation (CQV) activities associated with the Facility start-up project and supporting the
transition from project phase through to sustaining phase with respect to validation activities.

2 positions are available: 1 QA Specialist (3 yrs experience) & 1 QA Senior Specialist (5-6 yrs
experience).

Key Responsibilities:

• Oversee quality aspects of qualification/validation for facilities, utilities, equipment,
  computerized systems, cleaning and manufacturing processes, storage areas, CTUs, and
  shipping.
• Review and approve all validation documentation (plans, URSs, risk assessments, protocols,
  reports) for compliance with SOPs, specifications, and acceptance criteria.
• Provide QA oversight, review, and approval for events/deviations, investigations, and changes
  related to qualification/validation, ensuring adherence to SOPs and cGMP.
• Review SOPs associated with qualification/validation activities.
• Support regulatory inspections and client audits.
• Provide QA validation expertise to ensure facility validation status is maintained.
• Maintain up-to-date knowledge of cGMP regulations and validation/qualification
  requirements.
• Coordinate QA validation activities to meet schedules and deliverables.
• Manage and develop the QA Validations team (performance management, recruitment,
  training).
• Perform other assigned quality activities as needed.

Preferred Experience:

• Level 8 degree (B.Sc./B.Eng.) in a scientific or engineering discipline.
• Experience in Quality Engineering/Assurance/Validation within biologics or related
  pharma/medical device manufacturing in FDA/EU-regulated environments.
• Strong understanding of cGMP facility validation requirements and solid technical aptitude.
• In-depth knowledge of GxP regulations (EU-GMP, FDA, ISO) and validation standards (GAMP,
  ISPE, ISO, ASME, BPE).
• Skilled in troubleshooting, problem solving, and root cause analysis tools (e.g., Ishikawa,
  FMEA).
• Independent, self-motivated, and effective in fast-paced environments with strong planning,
  organizational, time-management, and critical-thinking skills.
• Able to work across internal and external functional boundaries.
• On-site role.

Note:

This is an onsite role. All applicants must be willing to work onsite.
All applicants must be eligible to work in Ireland without Visa sponsorship now or in future.
Interested applicants, apply with your updated CV to:
[email protected] (Please specify role name –QA Specialist /QA
Sr. Specialist).

Apply Now

If you’re passionate about manufacturing excellence and eager to grow in a fast-paced, regulated environment, we want to hear from you.

Apply Now