Overview
Compliance Specialist:
In partnership with its client Kenny-Whelan & Associates is currently sourcing for a Compliance Specialist for the North Dublin area.
Profile of Role:
The Compliance Specialist conducts regulatory examinations and internal audits across the organization. He/She will conduct periodic Compliance reviews of departments, ensuring that procedures and guidelines are met. He/She will prepare documentation of internal procedures utilizing State and Federal rules, Regulations, Statutes and other third-party Compliance resources.
The successful candidate will prepare Compliance Manuals and Programs, develop Compliance Training Modules and Training of Compliance Team Members, perform Due Diligence visits and risk assessments.
The Compliance Specialist will support GMP and inspection readiness activities and as required collaborate with the Internal Audit team. The Specialist will ensure that objectives are effectively achieved, consistent with the company’s requirements to ensure Compliance, Safety and reliable Supply to our customers
Main duties and responsibilities:
- Provide Quality and cGMP input and oversight for GMP readiness activities
- Review and approval of pre executed and post executed protocols
- Review of technical support documentation
- Review of functional area documentation (SOPs, Work Instructions, technical reports and protocols)
- Provide support for internal audit and inspection readiness activities
QUALIFICATIONS AND EXPERIENCE
- Degree in Natural or Applied Sciences (Pharmacy, Biology, Biotechnology, Engineering)
- Minimum 5 years Pharmaceutical and/or Biotech industry experience in Quality/ Compliance related role
- Experience in startup facilities a distinct advantage
- Demonstrated problem solving capabilities
- Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements
- Ability to operate efficiently in a complex matrix organization and global environment
- Ability to self-motivate and work independently and as a team
- Strong leadership and interpersonal influencing skills
- Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels
- Excellent English fluency written and spoken (the Company language)
- Experience in Trackwise and SAP an advantage
All applications will be treated with the strictest confidence
Kenny-Whelan Contact:
For further information please contact Carmel Synnott on 00 353 21 4665405 / 087 7422268 or send your updated CV to [email protected]
