Validation Compliance Specialist

Ref. 1408

Validation Compliance Specialist

Our client is a leading global pharmaceutical company with multiple sites across Ireland. They currently have an exciting opportunity for a Compliance Specialist (Validation) to join their site in Carlow, offering an excellent opportunity for someone looking for a new challenge within a cGMP-regulated environment.

The successful candidate will provide compliance support across all areas of Validation, ensuring adherence to cGMP and regulatory requirements. The role will involve working both independently and as part of a cross-functional team to achieve validation and compliance objectives.

The ideal candidate will be comfortable working with moderate direction and will have a strong level of knowledge and experience relevant to the position.

Responsibilities:

·       Provide compliance support for validation activities

·       Support Regulatory, Divisional and Internal audits

·       Respond to operational and business areas, ensuring compliance with cGMP & 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 & approval of periodic revalidation plan & report, periodic review plan and of validation governance report

·       Generation & coordination of Annual Product Review validation chapters

·       Inspection readiness coordination & support including oversight of story board preparation and ensuring GMP compliant documents are available.

·       Review of validation documentation.

·       Investigation & RCA support.

·       Ensure compliance with the QMS, industry/company specific standards and regulations.

·       Demonstrate effective communication and interpersonal skills.

·       Demonstrate an awareness of own capabilities and development needs.

·       Support continuous improvement by active participation in, and contribution to, projects and problem-solving including use of MPS processes and tools.

·       Participate in driving a high performing & inclusive culture, stimulating personal growth & development.

·       Work collaboratively to drive a safe and compliant culture in the workplace.

·       May be required to perform other duties as assigned

Requirements:

The ideal candidate will have considerable experience in a similar role, with proven experience working independently and adding value within a GMP manufacturing environment. The following qualifications and skills are also required:

·       Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification, alongside with a proven track record in delivering excellence.

·       Exception / Deviation Management and Change Control.

·       Equipment Periodic Validation

·       Equipment Validation Lifecycle

·       Project Management Skills/Qualification

·       Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable

·       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 appropriate.

·       Report, standards, policy writing skills required.

·       Equipment and process validation.

·       Sterile Fill-Finish processes and equipment.

·       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 manner

·       Evidence of continuous professional development is desirable

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 & Parts Washers for in-process components.

·       Cleaning recovery studies using TOC and swab methods.

·       CCI qualification.

·       Shipping Qualification.

·       Filter Validation.

·       Vial and Syringe Processing Technologies