This company is still actively recruiting during the Covid 19 Crisis and where applicable are setting up new starters to work from home/conducting interviews via Skype. Quality Assurance Manager | Galway City
Reporting to the Site Manager, the QA Manager will be responsible for the Quality Assurance Systems at the Galway Manufacturing Facility. Location:
Galway City Pay:
45-55k DOE Contract:
1-year contract Responsibilities of the job:
- To manage your area of responsibility in line with the companies defined objectives, budgetary and KPI targets.
- To maintain an in-depth knowledge of the business and products, the customers, suppliers and the market dynamics.
- Manage and maintain good professional working relationships both internally and externally to the business.
- Maintain and promote the company’s Policies and Procedures, e.g. Safety, Quality, Ethics, etc.
- Prepare and propose plans both long and short term for your area of responsibility in line with the companies defined strategy and agreed financial targets.
- To review and propose new processes to advance the quality of work within your responsibility.
- Represent Quality Assurance in regulatory and customer audits and ensure the timely close out of NC actions / recommendations identified from all audits.
- Development and maintenance of the quality manual.
- To assist colleagues and personally develop all in-house documentation – including but not limited to Standard Operating Procedures, Validation Protocols, Risk Assessments & records
- Ensure the quality management system is implemented and effective. Report on trends monthly.
- Advise, facilitate and implement systems to ensure continuous improvement of processes & services
- Report incidents, field safety notices and pharmacovigilance issues to head office quality department monthly
- Ensure Vigilance reviews are conducted regularly
- Report incidents and field safety notices to the relevant Regulatory Body
- Report customer & regulatory audit findings to the Technical Director monthly
- Perform investigations into internal & external non-conformances using root cause analysis and develop corrective and preventive actions to improve the operation
- Investigate customer complaints in conjunction with the relevant departments using root cause analysis and develop corrective and preventive actions to improve the operation.
- Perform internal audits and report findings to the relevant managers.
- Report on cGMP & health and safety compliance as well as ISO 9001 compliance
- Co-ordination & participation in external audits. Liaising with other functions & departments in audit preparation. Document audit non- conformance and complete all relevant actions.
- Provide technical support to QC Lab and operations functions and Customers when requested.
- Approve change control notices as required
- Co-ordination of equipment calibration & maintenance including the maintenance of calibration records
- Manage and periodically audit the approved vendors list and maintain the current status. Perform supplier audits when required and maintain the supplier rating process
- Facilitate, approve and assist in all validations.
- Communication with LIP suppliers regarding customer technical queries or complaints
- Communication with the Sales Team regarding customer feedback
- Provide and record GMP training programme & induction training for new starters.
- Assist in regulatory and customer audits and ensure the timely close out of NC actions / recommendations identified from all audits.
- Lead the daily production meetings with support functions and ensure prioritisation of requirements and resources.
- Degree level qualification in a scientific subject
- Leadership experience
- Experience in a regulated pharmaceutical/medical device industry, preferably in a Quality function
- Experience in Risk management, Supplier Management, Customer Complaints, investigation techniques and root cause analysis
- HPRA/FDA audit experience
- ISO17025 experience
- Microbiology background
- Knowledge/Experience in Post Market surveillance and pharmacovigilance
- Knowledge/Experience in Validation and Sterilization
If you are a suitably qualified and experienced Quality Assurance Manager, please contact Aaron Long at Sigmar Recruitment T: +353 91 749 264 | E: firstname.lastname@example.org Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.