Document Controller

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:

This is an opportunity to be part of a dynamic team within the Quality function. 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.
The Document Controller works closely with many key departments in Chanelle daily ensuring that the customer’s needs and requirements are fulfilled.
In this role, you will report into Compliance Manager.

KEY RESPONSIBILITIES:

  • Maintain and update an efficient document control system which is compliant with company quality systems and GMP
  • Maintain an efficient archiving system enabling easy retrieval of documentation
  • Present quality procedures, i.e. Standard Operating Procedures, Finished Product Procedures, Entry Control Procedures, Calibration and Operating Instructions, QC Data  Sheets, Raw Material Analysis Sheets and Forms in accordance with predesigned formats
  • Change Control Administration – management of RCRB meetings, issuing change control numbers, preparing and obtaining signatures, reviewing change controls for closure, running regular reports and forwarding to originators/managers for status – if change can be closed, remain open, issues outstanding etc.
  • Ensure that training folder for QA Department is kept up to date
  • Carry out all administration duties function, such as filing, typing, record-keeping, and archival of completed documents. Ensuring all administration duties are kept up to date
  • Management of monthly stationery order for all departments
  • Management of the Employee Signatures Records
  • Ensure that quality procedures are followed and where appropriate suggestions/change notices prepared such that the Quality System can be continuously improved
  • Ensure timely feedback on queries as appropriate
  • Forwarding any incoming reports (whether it is through post, email, fax or in person) regarding Pharmacovigilance/adverse reaction reports to the relevant Customer/MAH in a timely manner
  • Ensure workstation is kept tidy and organised at all times
  • Any other duties as outlined by the Quality Manager/Designee
  • tain and update an efficient document control system which is compliant with company quality systems and GMP
  • Maintain an efficient archiving system enabling easy retrieval of documentation
  • Present quality procedures, i.e. Standard Operating Procedures, Finished Product Procedures, Entry Control Procedures, Calibration and Operating Instructions, QC Data  Sheets, Raw Material Analysis Sheets and Forms in accordance with predesigned formats
  • Change Control Administration – management of RCRB meetings, issuing change control numbers, preparing and obtaining signatures, reviewing change controls for closure, running regular reports and forwarding to originators/managers for status – if change can be closed, remain open, issues outstanding etc.
  • Ensure that training folder for QA Department is kept up to date
  • Carry out all administration duties function, such as filing, typing, record-keeping, and archival of completed documents. Ensuring all administration duties are kept up to date
  • Management of monthly stationery order for all departments
  • Management of the Employee Signatures Records
  • Ensure that quality procedures are followed and where appropriate suggestions/change notices prepared such that the Quality System can be continuously improved
  • Ensure timely feedback on queries as appropriate
  • Forwarding any incoming reports (whether it is through post, email, fax or in person) regarding Pharmacovigilance/adverse reaction reports to the relevant Customer/MAH in a timely manner
  • Ensure workstation is kept tidy and organised at all times
  • Any other duties as outlined by the Quality Manager/Designee

COMPETENCIES:

  • Excellent IT and administration skills.  Proficiency in Micosoft Outlook, Excel & Word essential.
  • 2+ years’ experience in and administrative role.
  • Strong organizational skills with excellent attention to detail.
  • Ability to work on own initiative.
  • Good communication skills but written & verbal.
  • Ability to build cross functional relationships quickly and effectively

QUALIFICATIONS:

  • 3rd level qualification.
  • Degree in Science.
  • Strong verbal and written communication skills
  • Strong computer skills in MS Office
  • Experience working within a pharmaceutical GMP Environment; with knowledge of EU GMP and US FDA Guidelines is desirable

Document Controller

Galway