KEY RESPONSIBILITIES:

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
role
• 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
requested
• Stability requirements to be agreed with customer. Generation of protocols/reports
should reflect same
• Product quality reviews to be prepared as per the schedule
JOB DESCRIPTION / SPECIFICATION
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
requirements
• Performing Internal audits as per the schedule

COMPETENCIES:

• 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.

QUALIFICATIONS:

• 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

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

• VDU

WORK ENVIRONMENT:

• Office