NPI Compliance Officer


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:

• Demonstrate excellent knowledge of current and pending EU GMP and US FDA requirements and
ensuring compliance with same.
• The position requires excellent inter-personal skills to assist in liaison with other departments within
the site in order to ensure compliance and productive working relationships
• Be self-motivated, flexible, organised and a good team player with the ability to prioritise own work
based on departmental and site requirements.
• Excellent verbal and written communication skills


Co-ordination and ensuring execution of the following across multi-disciplinary teams:

• Conducting risk assessments for the introduction of new products into Chanelle
and/or contract manufacturing site
• Review of all specifications and process against registered documents
• Generation of associated procedures
• Review & maintenance of QA Department SOPs ensuring compliance with functions of the
• Evaluating all materials both manufacturing and packaging to ensure full compatibility
and manufacturing capability is ensured.
• Review of the molecule and proposed equipment on existing cleaning validation studies.
• Ensuring that method development and validation of the cleaning analytical method
is conducted
• Ensuring that cleaning and process validation is executed – protocols, reports and
implementation of recommendations
• Method development/validation and/or analytical method transfer requirements for
API, excipient and finished product are fulfilled
• API evaluation including QC testing and collation of associated GMP documentation
• Scheduling audit requirements for API, primary packaging, artwork suppliers, any
contract manufacturing/packing/lab/warehouse involved, supply of QP declarations
• Stability requirements to be agreed with customer. Generation of protocols/reports
should reflect same
• Product quality reviews to be prepared as per the schedule
Form No. 17.1-10/3 Effective Date: 16/04/2020 Supersedes: 17.1-10/2
SOP/HR/046.2/4 CCF-20-0123 Page 2 of 3
• Conducting post launch review in order to identify areas requiring improvement
and amendment of procedures to address same
• Management of post launch variations with an impact on QA aspects
• Assessment of post launch data such as production rejects, complaints, ADRs, OOS,
stability data for any potential changes/variations required
• Implementation of changes prompted by variations approved post launch
• Meet deadlines as defined within the agreed project plan
• To work with R&D team on the technical transfer of products out of Chanelle’s R&D
production area and into Chanelle’s commercial production area.
• To work with R&D team on the technical transfer of products out of Chanelle’s R&D
production area and into Chanelle’s assigned Contract manufacturer
• Work with New Product Launch co-ordinators when transferring products into Chanelle and
into Chanelle’s contract manufacturing/testing sites
• Report to the Head of Quality on the status of all product introductions with regards to
compliance aspects
• To assist the receiving site with any problems/issues arising from the transfer process.
• To ensure that all work carried out is in compliance with the required standards i.e. GMP,
Health and Safety, Environmental and regulatory requirements.
• To liaise with the Veterinary & Medical Regulatory Affairs department in order to ascertain
visibility of products that are near registration, planning for such product launches need to
commence 6 months prior to grant of Regulatory approval/Issue of Product License.
• Liaise with Business Development Team to receive an introduction to various Customers who
have purchased ‘Product Licenses’ from Chanelle. Start to liaise with such Customers 6
months prior to grant of ‘Product Licenses’. Ensure alignment with Business Development and
Regulatory Affairs departments
• To liaise with Regulatory, Manufacturing, Operations, Engineering, Artworks, Purchasing and
Quality Control personnel as required.
• Confirming supply chain of all raw materials and finished products to meet regulatory
• Performing Internal audits as per the schedule


• Displays key behaviours such as

  • Takes direction and asks question
  • 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
  • Any other duties as assigned by the Head of Quality/ QA Manager.



  • Bachelor’s degree in a science-based or regulatory based discipline with a minimum of 4 years’
    experience in a pharmaceuticals manufacturing environment with working knowledge of EU GMP and
    US FDA Guidelines

Health & Safety requirements (eg. Manual Handling Training)

  • VDU



  • Office

NPI Compliance Officer

Reference No: J0355