My client a Cork based pharmaceutical company has an opening for a Compliance Manager.
The duties of the role will include the planning and execution of audits to assess ongoing compliance.
Other duties include :
• Prepare and lead GMP audits across multiple internal sites and third parties
• Identify compliance risks against current regulatory requirements and standards.
• Provide timely audit reports, and data entry into the ERP data tracking system.
• Develop and train audit team members.
• Develop and improve compliance processes, integrate global systems and provide related training.
• Serve as an internal consultant in interpretation of regulatory requirements and expectations.
• Represent Compliance in various forums and project teams.
• Other duties as assigned and an understanding that a small amount of international travel is required.
• Must have wide-ranging and broad GMP compliance experience.
• Contribute to development of company objectives and principals.
• 8 -10 years of experience in pharmaceutical, biotech and/or medical device industry.
• Experience in sterile operations is highly desirable, but not essential.
• 3 - 5 years compliance auditing experience.
• Knowledge of GMP and GDP regulations (US, EU and Japan) and related guides and standards.
• Demonstrated lead auditor skills.
• Strong interpersonal skills, including excellent influencing and negotiating skills.
• Demonstrated ability to identify compliance issues & analyze effectiveness of proposed CAPA's
• Flexible and team work approach.
• Project management and troubleshooting skills.
• Ability to communicate effectively both written and orally to all levels of management.
This role comes with an excellent salary package with benefits.
If interested please call Colin for a confidential discussion on 021-4847131 or E-Mail firstname.lastname@example.org