QA Compliance Officer

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 QA function.  We are looking for an individual 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.

In this role you will report into the QA Manager

KEY RESPONSIBILITIES:

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

  • Prepare and Maintain ASL packs with required documentation for raw materials, APIs and third party products.

  • Approving of product codes for the launch products

  • Approving BOMs and revision to BOMs

  • Approving Artwork change requests as and when required

  • Conduct Routine Quality Audits of the facility to ensure compliance, be proactive in resolving issues which may arise.

    • Management of Medical TAs in line with Chanelle and customer requirements.
    • Set up and maintain the Internal Audit schedule and ensure its completion as per schedule.
    • Prepare and conduct annual GMP training programme for the site.
    • Interaction with QPULSE OMS to ensure quality records such as Deviations, SCARS, Rejection Notices and CAPAs are reviewed, approved and appropriately closed in line with target completion dates.
    • Management and assistance with the site change control system.
    • Management of customer compliant system
    • Management of QMRB meeting
    • Provide technical support to the MAH for New Product Introductions and existing Products.
    • 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 MWO’s & PWO’s for the Chanelle group.
    • Provision/Updating of existing Quality Procedures in line with issues as they arise as result of validation in cooperation with the appropriate department.
    • Contributing to the overall improvement of the company from a Quality/GMP perspective with an emphasis on continuous improvement of the quality system.
    • Maintenance of records for the company KPls as per Quality management review requirements.
    • Ensure timely feedback on customer/production queries as appropriate.
    • Preparing product quality review reports as specified in Chapter 6 of Eudralex for the Chanelle group.
    • Preparation and review of Investigation reports and risk assessments
    • Preparation and review of Standard Operating Procedures, Cleaning Instructions, Preventive Maintenance procedures and Process Operating Instructions.
    • Providing GMP training to all employees new and existing.
    • Assist in trouble-shooting product problems.
    • Any other duties assigned by the Head of Quality.Host Customer and Regulatory audits and follow through with CAPA responses as appropriate.
  • Maintenance of company MIA in line with Regulatory variations

COMPETENCIES:

  • Organizational skills, personal efficiency, time management skills and the ability to prioritize competing demands are key communication skills.
  • Ability to build relationships and collaborate with others is vital.
  • Strategic decision-making within the business as an influencer.
  • A strong working knowledge of best practice processes, change management implementation, coaching and mentoring.
  • Demonstrated ability in prioritizing key initiatives, driving growth and setting targets and KPIs to monitor the performance
  • Positive and proactive person who is energized by having great responsibility
  • Practical, action-orientated approach to managing priorities and teams.
  • Strong computer skills in MS Office

QUALIFICATIONS:

  • A Bachelor’s degree in a Science related discipline.
  • Desirable a minimum of 3 years’ experience of working in a similar Quality Assurance related role in the Pharmaceutical Industry.
  • Knowledge of EU quality-related pharmaceutical regulations.

QA Compliance Officer

Galway