MA Compliance Manager

Loughrea, Co. Galway

BASIC SUMMARY:

This is an opportunity to be part of a dynamic team within the QA function.  We are looking for individuals who will support and drive Chanelle Pharma’s vision to be the most valued global provider of high quality, competitively priced pharmaceutical products and to provide excellent services and support to our customers.

In this role you will report into the Senior QA Manager

KEY RESPONSIBILITIES:

  • Overall Management of the Post MA Compliance Team within Chanelle Pharma.
  • Maintenance of the post MA Compliance Folder to ensure compliant and approved dossier on file (Module III and Part 2b).
  • Managing the CCF’s for post implementation following generation of PLCL from Regulatory Department within the QMS
  • Ensuring all Workorders are reviewed and approved all new work orders against currently approved dossier .
  • Ensuring all Procedures are reviewed and approve release and shelf life
  • Ensuring Validation Protocols are reviewed against currently approved dossier.
  • Approval of Shelf life data. The list will be maintained by MA Compliance personnel.
  • QTA review and approval (where applicable)
  • Maintenance of Procedures in line with in-house requirements.
  • Report Non-conformances within a timely manner
  • Implement suggestions for improvement / development of the Quality System
  • Create and Present monthly and quarterly metrics.
  • Any other duties as assigned by the Director of Quality/ Associate Director Quality

COMPETENCIES:

  • Organisational skills, personal efficiency, time management skills and the ability to prioritise competing demands are key communication skills.
  • Ability to build relationships and collaborate with others is vital.
  • Strategic decision-making within the business as an influencer.
  • A strong working knowledge of best practice processes, change management implementation, coaching and mentoring.
  • Demonstrated ability in prioritising key initiatives, driving growth and setting targets and KPIs to monitor the performance
  • Positive and proactive person who is energized by having great responsibility.
  • Practical, action-orientated approach to managing priorities and teams.
  • Strong computer skills in MS Office

 

QUALIFICATIONS:

  • Bachelor’s degree in Quality or Science based discipline.
  • Minimum of 2-4 years’ experience in a GMP manufacturing environment with working knowledge of EU GMP and US FDA Guidelines essential.
  • Experience working in pharmaceutical preferred however medical device industry experience will also be considered.
  • Excellent Report Writing and IT Skills.
  • Demonstrated hands on experience of delivering a best-in-class QA function in a similar role.

 

PHYSICAL DEMANDS: Health & Safety requirements (e.g., Manual Handling Training)

  • Manual Handling
  • VDU

 

WORK ENVIRONMENT: (e.g., Office, Production)

  • Office

MA Compliance Manager

Reference No: J0749
Loughrea, Co. Galway