Validation Compliance Specialist

PSC Biotech Corporation; Carlow; On-site; EUR 70,000 - 90,000; Full time

Job summary

PSC Biotech Corporation in Carlow, Ireland, seeks a Compliance Specialist (Validation) with 5+ years in GMP environments to support validation activities across the site.

You will maintain the Validation Master Plan, coordinate periodic revalidations, and prepare governance reports, while ensuring regulatory compliance and effective communication with cross-functional teams.

This permanent role offers exposure to top pharmaceutical clients and a dynamic, diverse culture.

Qualifications

• Experience in GMP manufacturing environments.
• Strong knowledge of validation lifecycle and documentation.
• Experience with Deviation Management and Change Control.
• Familiarity with regulatory/code requirements.

Responsibilities

• Provide compliance support for validation activities.
• Support Regulatory, Divisional and Internal audits.
• Maintain Validation Master Plan.
• Prepare and approve periodic validation reports.
• Review validation documentation for GMP compliance.
• Collaborate to drive a safe, compliant culture.

Skills

GMP experience

Validation

Documentation

Audit readiness

Change control

Deviation management

Equipment qualification

DeltaV

PI System

Communication skills

Team collaboration

Education

Applied Pharmaceutical / Biological Sciences degree

Tools

DeltaV

PI System

Job description

• Industry Pharma/Biotech/Clinical Research
• Work Experience 5+ years
• City Carlow
• State/Province Carlow
• Country Ireland

Job Description

About PSC Biotech

Who are we?

PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350 clients in morethan 23 countries worldwide. We provide cloud-based software solutions forQuality Management and Regulatory Inspections, pharmaceuticals contractmanufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-minded professionalsoperating in the Pharma/ Biotech Industry. We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse-cultural work setting.

Employee Value Proposition

Employees are the “heartbeat” of PSC Biotech, we provideunparalleled empowering career development though Learning & Developmentin-house training mentorship through constant guidance to facilitate careerprogression. We believe in creating high performing teams that can exceed ourclient’s expectations with regards to quality of all scalable and business unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met.

Role:

Our site are excited to offer a fantastic ComplianceSpecialist (Validation) for candidates interested in a new challenge in a cGMPregulatory environment. The successful candidate will provide compliance support toall areas of Validation, ensuring compliance to cGMP C regulatory requirements.

Requirements

Bring energy, knowledge, innovation to carry out thefollowing:

• Provide compliance support for validation activities
  
• Support Regulatory, Divisional and Internal audits
  
• Respond to operational and business areas, ensuringcompliance with cGMP C regulatory requirements
  
• Accountable for compliance via documentation completion,risk assessments, closing out corrective actions and proactively highlightingany issues around compliance
  
• Responsible for maintaining site Validation Master Plan
  
• Generation & approval of periodic revalidation plan Creport
  
• Generation & approval of periodic review plan
  
• Generation & approval of periodic governance report
  
• Generation & coordination of Annual Product Reviewvalidation chapters
  
• Inspection readiness coordination C support includingoversight of story board preparation and ensuring GMP compliant documents are available.
  
• Review of validation documentation.
  
• Ensure compliance with the QMS, industry/company specificstandards and regulations.
  
• Demonstrate effective communication and interpersonalskills.
  
• Proactively , consistently improve personal knowledge andcapability.
  
• Demonstrate an awareness of own capabilities anddevelopment needs.
  
• Support continuous improvement by active participationin, and contribution to, projects and problem-solving including use of MPSprocesses and tools.
  
• Participate in driving a high performing C inclusiveculture, stimulating personal growth and development.
  
• Work collaboratively to drive a safe and compliantculture
  
• May be required to perform other duties as assigned
  

What skills you will need:

• In order to excel in this role, you will more than likelyhave considerable experience in a comparable role, with experience operating asindividual contributor adding value to the business in a GMP manufacturingsetting, as well as the following qualifications/skills:
  
• Relevant technical qualification(s) in AppliedPharmaceutical / Biological /
  
• Chemical sciences or applied Technical / Engineeringqualification, the successful candidate will also have a proven track record indelivering excellence.
  
• Exception / Deviation Management and Change Control.
  
• Equipment Periodic Validation
  
• Equipment Validation Lifecycle
  
• Project Management Skills/Qualification
  
• Knowledge of process monitoring systems, automationsystems (DeltaV), operational intelligence C data systems (Pi System) within aGMP manufacturing environment would be beneficial
  
• Evidence of continuous professional development isdesirable.
  
• Knowledge of regulatory/code requirements to Irish,European and International Codes, Standards and Practices.
  
• Ability to analyse and interpret complex data, and linkto equipment performance and out of specification findings as appropriate.
  
• Equipment and process validation.
  
• Sterile Fill-Finish processes and equipment.
  
• Proficiency in Microsoft Office and job-related computerapplications required
  
• Excellent communication, presentation and interpersonalskills, to interface effectively with all levels of colleagues and withexternal customers in a team orientated manner.
  
• Knowledge and experience of the below areas will beconsidered advantageous
  
• Isolator VHP/HVAC Qualification
  
• Controlled Temperature Units/Equipment Qualification
  
• Validation of Tank CIP C Parts Washers for in-processcomponents.
  
• Cleaning recovery studies using TOC and swab methods.
  
• Shipping Qualification.
  
• Filter Validation.
  
• Vial and Syringe Processing Technologies