Quality Manager
- Employer
- Thornshaw Recruitment
- Location
- Mayo (County), Connacht (IE)
- Salary
- Depending on experience
- Start date
- 30 Jun 2022
- Closing date
- 30 Jul 2022
Job Details
My client is recruiting for a Quality Manager to join their team in Co. Mayo. You will be reporting to the CVP Global Biologics QA and this is a full-time permanent position.
Profile and Requirements
This role shall be responsible for managing the GMP Quality Assurance program to assure compliance with regulatory requirements and minimize any business interruption. With 9 direct reports, this role shall also assist Regulatory Affairs and Compliance management in implementing their Compliance Program.
• Develop departmental policies and procedures to assure applicable regulatory requirements are fulfilled.
• Manage direct reports to assure that Quality Assurance responsibilities of applicable regulations are fulfilled.
• Assure staff receives appropriate regulatory training and mentoring to enable the execution of regulatory responsibilities.
• Assist in the development and presentation of regulatory training for Quality Assurance and operations staff.
• Review and endorse Quality Assurance reports of audits and inspections to assure proper and consistent interpretation of regulatory requirements and corporate policies.
• Assure that all records and reports are prepared, communicated, and retained in accordance with applicable regulatory requirements.
• Interface with Regulatory Agencies during inspections.
• Administer programs for measuring compliance and quality through pertinent metrics on key performance indicators and provide periodic reports to management.
• Represent the corporation during regulatory and client inspections/audits.
• Prepare site/operation personnel for client and regulatory audits and prepare appropriate summaries and reports of such audits.
• Coordinate the preparation of regulatory and client audit responses and corrective action commitments.
Requirements:
• BSc. in a relevant Science discipline.
• 5-10 years’ experience of working within a GLP/GMP environment with at least 5 of those in a Manager/Supervisor role.
• Previous quality auditing experience essential especially dealing with regulatory bodies such as HPRA & FDA.
If you are interested in applying for this role, please call Zoe on +353 1 2784671 or email zhamilton@thornshaw.com
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com
Company
Thornshaw Scientific Recruitment was first established in 1999 and since then has become a leader in Scientific recruitment. In 2005 we partnered with Cpl Resources, one of Europe’s most successful recruitment companies.
Our wealth of experience in specialised recruitment allows us to offer the right solution to each employer, whatever their recruitment requirements.
Over the years we have developed strong relationships with our clients in the market and we pride ourselves on our repeat business from clients.
Our Industries
We are a global provider and have been providing a reputable recruitment service to the Biotech, Pharmaceutical, Clinical Research, Medical Device, Engineering and Healthcare industries for over 20 years.
Our Specialities
Clinical Research, Regulatory Affairs, Quality Assurance, Medical Affairs, Pharmacovigilance, Biostatistics, QC, Validation.
Our Mission
For further details on our services contact Tina at +353 1 2784701 or email tdunne@thornshaw.com
- Website
- http://www.thornshaw.com/
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