Senior QA Compliance Officer/QP


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:

An important role in the QA department, the ideal candidate will demonstrate excellent knowledge of current and pending EU GMP requirements and FDA Regulations ensuring compliance with same, have excellent verbal and written communication skills, and will have the opportunity to fulfil the duties of QP, and assist in the process of maintaining compliance to Product Licences / Marketing authorisations.


· Responsibility for batch release as per EU guidelines by ensuring the following requirements have been met:

o the batch and its manufacture comply with the provisions of the marketing authorisation (including the requirements for importation where relevant);

o manufacture has been carried out in accordance with GMP (in the case of an imported batch that it has been manufactured to standards equivalent to EC GMP);

o the principal manufacturing and testing processes have been validated (account has been taken of the production conditions by review of the relevant documentation);

o any deviations or planned changes have been duly authorised. Any changes requiring variation to the marketing authorisation have been notified and authorised by the relevant authority.

o all the necessary checks and tests have been performed;

o all necessary production and Quality Control documentation has been completed and endorsed by the appropriate staff;

· Forward any incoming reports (whether it is through post, e-mail, fax or in Person) regarding Pharmacovigilance / Adverse Action Reports to the relevant QPPV in a timely manner.

· all audits have been carried out as required by the QA system;

· take into consideration any other relevant factor that may affect the quality of the batch.

· Conduct Routine Quality Audits of the facility to ensure compliance with current EU GMP, be proactive in resolving issues which may arise.

· Set up and maintain the Internal Audit schedule and ensure its completion as per schedule.

· Prepare and conduct annual GMP training programme.

· Conduct External audits, compile External Audit reports and manage associated responses.

· Management and assistance with the site change control system.

· Management of the customer complaints system and associated CAPA’s.

· Provide technical support for New Product Introductions and existing Products, ensuring compliance with the registered dossier

· Review /lead Process investigations and ensure any such investigations are documented appropriately with relevant corrective actions, if necessary.

· Ensure Process transfer is documented and conducted in accordance with Regulatory Standards.

· Quality review and approval of manufacturing documentation for Chanelle & third party contract manufacturing.

· Provision / Updating of existing Quality Manual Procedures in order to ensure compliance with EU GMP

· Contributing to the overall improvement of the company from a Quality / GMP perspective with an emphasis on continuous improvement of the quality system.

· Preparation of Key Performance Indicators for the Quality department and also assisting in the maintenance of records for the company KPIs as per Quality management review requirements.

· Ensure timely feedback on customer/production queries as appropriate.

· Preparing product quality review schedule and reports for Chanelle and third party contract manufacture products.

· Assist in product investigations and ensuring risk assessment approach is applied

· Management of the deviation system and associated CAPA’s.

· Collating monthly trends and assisting the Quality Material Review Board meetings.


· Bachelor’s degree in a science-based discipline with a minimum of 1-2 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


Health & Safety requirements (eg. Manual Handling Training)

  • VDU



  • Office

Senior QA Compliance Officer/QP

Reference No: J0412