On-Site Validation Specialist – GMP & Global Impact

PCI TRGR Penn Pharmaceutical Services Ltd; Killiney; In loco; EUR 42.000 - 62.000; Tempo pieno

Descrizione del lavoro

PCI Pharma Services in Stamullen, County Meath, Ireland, seeks a Validation Specialist to implement and execute tasks across Process, Facility and Equipment Validation. The role is permanent and on-site, with duties spanning PV, CV and CSV activities to meet client expectations and regulatory requirements.

The ideal candidate will have a related degree and at least two years’ experience in a GMP or regulated environment, plus strong problem solving, communication and organizational skills.

Competenze

• Bachelor's or associate degree in Quality / Validation.
• Minimum 2 years’ experience in Manufacturing or Quality.
• Capability to follow clear goals and meet predefined targets.
• Proficient in Microsoft Office products.
• Experience in GMP or Regulated Environments.

Mansioni

• Ensure safe work practices and report near misses immediately to the EHS Department.
• Ensuring validation activities meet regulatory requirements (HPRA/ FDA).
• Comply with Site Validation Master Plan.
• Generate validation protocols and review/approve reports.
• Maintain documentation for cleaning validation at PCI sites in Ireland.
• Execute validation activities with minimal supervision with other teams.
• Perform sampling in support of validation studies, including AQL.
• Manage tooling validations and associated documentation.
• Support investigations and change controls as required.
• Undertake ad hoc projects to meet business needs.
• Identify opportunities for improving processes and procedures.
• Perform periodic reviews and revalidations.
• Work with Validation team to ensure a robust system.

Conoscenze

Validation

GMP

Quality Assurance

Microsoft Office

Problem Solving

Communication

Flexible shifts

Formazione

Bachelor's or Associate in Quality/Validation

Strumenti

Excel

PV

CSV

Descrizione del lavoro

PCI Pharma Services in Stamullen, County Meath, Ireland, seeks a Validation Specialist to implement and execute tasks across Process, Facility and Equipment Validation. The role is permanent and on-site, with duties spanning PV, CV and CSV activities to meet client expectations and regulatory requirements.

The ideal candidate will have a related degree and at least two years’ experience in a GMP or regulated environment, plus strong problem solving, communication and organizational skills.