SIGMAR RECRUITMENT

SIGMAR RECRUITMENT

QA MANAGER


Posted on:
24/07/2020
Location:
GALWAY
Salary:
EUR 45,000 - 55,000
Job type:
PERMANENT
Job reference number:
15505046
Client ID:
ALQMGC2
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.
Essential:

  • 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
Desired:

  • HPRA/FDA audit experience
  • ISO17025 experience
  • Microbiology background
  • Knowledge/Experience in Post Market surveillance and pharmacovigilance
  • Knowledge/Experience in Validation and Sterilization
Interested? If you are a suitably qualified and experienced Quality Assurance Manager, please contact Aaron Long at Sigmar Recruitment T: +353 91 749 264 | E: along@sigmar.ie

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