Quality , Science, Pharmaceutical & Food

Senior Quality Manager

  • Full Time
  • Remote
  • Cork
  • 41937620

We are currently assisting our client in recruiting Senior Quality Manager for one of our generic pharmaceutical clients based in East Cork. This role will be responsible for compliance with cGMP’s, management of the SGS Private Label quality management system, quality assurance processes, supplier qualification, new product introduction and maintenance of existing finished products including brand guidelines and artwork. This is a permanent role with lots of scope to grow out the team and develop your own career.

The Role:

  • Ensure compliance with cGMP’s and company Polices & Procedures.
  • Promote the maintenance of a safe, accident free and healthy work environment.
  • Manage & develop direct reports – perform regular one to one meetings with direct reports to manage team’s performance & development.
  • Manage all processes of the Quality Management System example, deviations; change control, complaints, document control system, record retention & CAPA.
  • Manage the electronic Quality Management System & record retention.
  • Manage activities to ensure timely & compliant launch of finished products such as NDC/UPC code management, artwork & regulatory submissions are complete and ensure non RLD & RLD artworks for drug product updates are completed.
  • Manage product quality related issues including the Product Review Board, escalate as required & bring to resolution.
  • Manage the Quality Management Review metrics, meetings & the actions resulting from the QMR meeting.
  • Manage the Deviation, CAPA & Training Processes with key stakeholders including identification of areas for improvement.
  • Manage the Complaint, Adverse Event & Query processes and co-ordinate responses with suppliers & customers.
  • Oversee the supplier regulatory affairs activities to ensure product artwork & regulatory submissions are compliant and completed in a timely manner.
  • Manage the Change Control process and communication of changes with suppliers.
  • Manage & develop the key performance indicators (KPIs) to monitor areas of responsibility and identify areas for improvement.
  • Manage new & existing SOPs for areas of responsibility.
  • Manage the quality assurance review of supplier quality procedures, records & approvals.
  • Manage the supplier & manufacturer qualification & monitoring process and escalate compliance concerns that may require further due diligence.
  • Manage recalls, withdrawals internally and oversee field alert requests and notice of actions with suppliers & the USFDA.
  • Develop and implement Standard Operating Procedures.
  • Maintain familiarity with current quality & regulatory trends.
  • Function as Deputy to the VP SGS Private Label Quality.
  • Perform related duties as assigned.

Requirements

  • BSc in a scientific discipline
  • 5 years in a cGMP facility in a Laboratory role.
  • Previous experience in managing or supervising direct reports is essential
  • Experience in HPLC and UPLC (High Performance Liquid Chromatography), method development & validation including equipment & software qualification is required. Knowledge of lean laboratory operations would be an advantage.
  • Experience using project management tools is desirable.

If you are interested in learning more about this exciting role please forward CV to Aoife.lomasney@peglobal.net or call Aoife on 0860200448

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland****

 

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