Desired Skills: Validation,Compliance,Technical Writing,GMP,Equipment Qualification,SOPs

ROLE

Our Carlow site are excited to offer a fantastic Compliance Specialist (Validation) for candidates interested in a new challenge in a cGMP regulatory environment. The

successful candidate will provide compliance support to all areas of Validation, ensuring compliance to cGMP C regulatory requirements.

Bring energy, knowledge, innovation to carry out the following:

• Provide compliance support for validation activities at our Carlow site.
• Support Regulatory, Divisional and Internal
• Respond to operational and business areas, ensuring compliance with cGMP C regulatory requirements
• Accountable for compliance via documentation completion, risk assessments, closing out corrective actions and proactively highlighting any issues around compliance
• Responsible for maintaining site Validation Master Plan
• Generation C approval of periodic revalidation plan C report
• Generation C approval of periodic review plan
• Generation C approval of validation governance report
• Generation C coordination of Annual Product Review validation chapters
• Inspection readiness coordination C support including oversight of story board preparation and ensuring GMP compliant documents are
• Review of validation
• Investigation C RCA
• Ensure compliance with the QMS, industry/company specific standards and regulations.
• Demonstrate effective communication and interpersonal
• Proactively C consistently improve personal knowledge and

• Demonstrate an awareness of own capabilities and development
• Support continuous improvement by active participation in, and contribution to, projects and problem-solving including use of MPS processes and
• Participate in driving a high performing C inclusive culture, stimulating personal growth C
• Work collaboratively to drive a safe and compliant culture in
• 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 likely have considerable experience in a comparable role, with experience operating as individual contributor adding value to the business in a GMP manufacturing setting, as well as the following qualifications/skills:

• Relevant technical qualification(s) in Applied Pharmaceutical / Biological /

Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record in delivering excellence.

• Exception / Deviation Management and Change
• Equipment Periodic Validation
• Equipment Validation Lifecycle
• Project Management Skills/Qualification
• Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence C data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable
• Evidence of continuous professional development is
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
• Ability to analyse and interpret complex data, and link to equipment performance and out of specification findings as
• Report, standards, policy writing skills
• Equipment and process
• Sterile Fill-Finish processes and
• Proficiency in Microsoft Office and job-related computer applications required
• Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated

Knowledge and experience of the below areas will be considered advantageous

• Autoclave/SIP Sterilisation Validation
• Dry Heat Sterilisation
• Isolator VHP/HVAC Qualification
• Controlled Temperature Units/Equipment Qualification
• Validation of Tank CIP C Parts Washers for in-process
• Cleaning recovery studies using TOC and swab
• CCI
• Shipping
• Filter
• Vial and Syringe Processing Technologies

The successful candidate will be required to work both independently and in a cross-

functional team to accomplish validation compliance objectives. Works with moderate work direction and is skilled and knowledgeable to the position.

Interested candidates should submit an updated CV. Please click the link below to apply or alternatively send an up-to-date CV howie.leahy@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland****