QA Compliance Officer

Galway

About Chanelle Pharma:

Chanelle Pharma is Ireland’s largest indigenous generic pharmaceutical manufacturer of both medical and veterinary products.

Serving customers in 96 countries worldwide, Chanelle Pharma is a partner of choice in the development and manufacturing of pharmaceutical products to the world’s leading human generic and animal health multinationals and distributors. We are passionate about understanding and addressing the challenges facing our medical and veterinary customers and bringing them innovative and effective products and solutions. 

The Opportunity:

This is an opportunity to be part of a dynamic team within the Quality functions, working closely with the other relevant functions within the business. 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. When working as part of this role, you will demonstrate excellent knowledge of current and pending EU GMP and US FDA requirements and ensuring compliance with same. You will have excellent verbal and written communication skills and fulfil the duties of QA Compliance Officer.

In this role you will report into the Quality Manger.

RESPONSIBILITIES:

  • Responsible for Quality Complaints Programme.
  • Ensure timely acknowledgement of Customer Complaints and Appropriate logging within the QMS.
  • Ensure reports are written and approved within the required timeframe.
  • Forwarding any associated Product Quality Defects to the respective Pharmacovigilance department.
  • Liaising with the HPRA for product quality defects reporting.
  • Review / lead Process investigations / Risk Assessment Documents and ensure any such investigations are documented appropriately with relevant corrective actions, if necessary.
  • Support with Review and approval of Compliance documents e.g. Deviations, SCARS and CAPAs.
  • Conduct Routine Quality Audits of the facility to ensure compliance, be proactive in resolving issues which may arise.
  • Conduct annual GMP training to respective GMP Areas as and when scheduled.
  • Quality review and approval of MWO’s & PWO’s.
  • Provision/Updating of existing Quality Procedures.
  • Contributing to the overall improvement of the company from a Quality/GMP perspective with an emphasis on continuous improvement of the quality system.
  • Preparing product quality review reports.
  • To carry out GMP walks as required.
  • Support during Quarantine and Recall activities.
  • Support or where necessary lead Quality based projects including working as part of a multidisciplinary team as required.
  • Participation in the self-inspections, internal and regulatory audits and ensuring necessary corrective actions are put in place.
  • Support and participation in the monthly Quality Management & Review.
  • Any other duties assigned by Quality Management

 

PERSON SPECIFICATION:

  • Bachelor’s degree in a science-based discipline with a minimum of 2-4 years’ experience in a pharmaceutical manufacturing environment with working knowledge of EU GMP and US FDA Guidelines.
  • Displays key behaviours such as:
    • Takes direction and asks questions
    • Relates well to the rest of the team
    • Develops own technical skills
    • Takes a methodical, systematic and structured approach to organising work
    • Ability to prioritise decision making differentiating between urgent and non-urgent
    • Escalates issues appropriately
    • Offers to help others when needed and creates a sense of harmony in the team
    • Displays flexibility and shows willingness to learn and do that little bit extra
    • Excellent Report Writing Skills

 

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

N/A

 

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

Office

 

QA Compliance Officer

Galway