Compliance Officer/QP

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. 

Building on over 35 years of research and development, with over 4,500 licenses registered worldwide, Chanelle Pharma is headquartered on an 18-acre campus in Loughrea, Co Galway, with three manufacturing facilities, four research and development laboratories and a fifth R&D laboratory in Jordan. The company employs 550 people in Ireland, UK, Jordan and India. At Chanelle Pharma our employees drive our success and you will have the opportunity to collaborate in our diverse and inclusive environment, the ability to learn and grow in your career, and an opportunity to make a direct impact on our business and customers. 

Chanelle Pharma has a proven track record of innovation and makes a significant investment in R&D annually and has doubled its sales growth in the last 5 years.

In 2018, the company announced an €85 million investment, the single largest investment by any Irish owned company, to double manufacturing capacity, launch 96 new products and grow its workforce to 850 people over a period of 5 years. As part of the investment, Chanelle opened a purpose built €10 million manufacturing facility in 2018 for the company’s expansion plans into the US market. The facility received FDA approval in September 2019.

Chanelle Pharma is on an ambitious growth trajectory and expanding its workforce across a number of disciplines in science, engineering, quality, finance, sales and marketing.  The company won 2018 Pharma Company of the Year and Industry Company of Year, the first indigenous Irish company to win the award.

 

The Opportunity:

To assist in the process of maintaining compliance to Product Licences / Marketing authorisations and batch certification accordingly.

 

In this role you will report to the Senior QA Compliance Manager/QP

KEY RESPONSIBILITIES:

  • Responsibility for batch release as per EU guidelines by ensuring the following requirements have been met:
  • the batch and its manufacture comply with the provisions of the marketing authorisation (including the requirements for importation where relevant);
  • 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);
  • the principal manufacturing and testing processes have been validated (account has been taken of the production conditions by review of the relevant documentation);
  • Any deviations or planned changes have been duly Any changes requiring variation to the marketing authorisation have been notified and authorised by the relevant authority.
  • all the necessary checks and tests have been performed;
  • 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
  • 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
  • Conduct Routine Quality Audits of the facility to ensure compliance with current EU GMP, be proactive in resolving issues which may
  • Set up and maintain the Internal Audit schedule and ensure its completion as per
  • Prepare and conduct annual GMP training
  • Conduct External audits, compile External Audit reports and manage associated
  • Management and assistance with the site change control
  • 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
  • Ensure Process transfer is documented and conducted in accordance with Regulatory
  • 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
  • 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
  • Ensure timely feedback on customer/production queries as
  • Preparing product quality review schedule and reports for Chanelle and third party contract manufacture
  • 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
  • Perform 3rd party management activities, including audit of suppliers and contract resource organisations, utilizing third party assessment
  • Review and approve process and cleaning validation protocols and reports

 

COMPETENCIES

  • Organizational skills, personal efficiency, time management skills and the ability to prioritize competing demands are key communication
  • Ability to lead a team and manage diverse personalities and
  • Ability to build relationships and collaborate with others is
  • Practical, action-orientated approach to managing priorities and

 

QUALIFICATIONS:

  • As a Qualified Person, is personally accountable to conform to the legal regulatory requirements as stated – Directives 2001/20/EC and Article 51 of Directive 2001/83/EC.
  • Minimum 5 years’ experience in a similar role
  • Experience of implementing and maturing a quality management system
  • Proven experience in change and project management
  • Ability to develop and lead continuous improvement initiatives
  • Experience of direct line management

Compliance Officer/QP

Galway