Description
A global pharmaceutical company based in Waterford are urgently seeking a Compliance manager.Role Summary:
* To ensure the company's Inhalations, and Research and Development Business Units operate in accordance with regulatory requirements by effectively managing the Compliance function.
* To ensure that the Documentation Services are managed effectively.
* To ensure all quality systems are effective and efficient in ensuring overall site compliance with GMP requirements.
Key Responsibilities include:
Compliance
* Conduct simulated FDA pre-approval and post-approval inspections and simulated IMB/PICS inspections to ensure the Company is at all times ready for audit.
* Ensure that the site is at all times in Compliance.
* Support The company's corporate Compliance initiatives.
* Ensure site Pharmacovigilance responsibilities are met.
* Manage Documentation Department and ensure all site documentation is appropriately controlled.
* Maintain and improve the Company Quality System in accordance with Regulatory and Business requirements.
* Maintain and improve the Company Compliance systems in accordance with Regulatory and Business systems.
* Ensure that all work carried out is in compliance with the required standards conforming to Company, GXP, SOPs, Regulatory requirements and guidelines, including H & S and Environmental guidelines.
Customer Service
. Deliver excellent Customer Service (both internal and external) through agreed timelines in accordance with Quality standards and cost control.
Qualifications / Experience:
*Degree in science related discipline.
*QP eligibility desirable.
*Quality Management experience in FDA approved facility.
*Quality Assurance/Quality Auditing experience desirable.
Key Skills/Competencies:
* Excellent Knowledge of cGMP, GLP, Regulatory Authorities and Customer requirements.
* Knowledge of Company policies, procedures and standards.
* Excellent Knowledge of the regulatory standards within the Pharmaceutical Industry.
* Health & Safety/Environmental Legislation.
* Employment Legislation.
* Report Writing.
* Computer literate.
This is an extremely urgent requirement; interviews must take place this week. If you are interested in this great opportunity and have the relevant skill set and experience please contact me Anna Mooney
For immediate consideration apply below with an up to date CV