QA Validation Engineer
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.
An important role in the QA department, reporting directly to the Head of Quality, the Validation Engineer will be responsible for reviewing and issuing of validation protocols and reports and also the co-ordination of the execution of validation activities (process / cleaning and equipment and computer qualifications) with the relevant departments within the Chanelle Group.
In this role you will report into the Head of Quality.
The key responsibilities of the QA Validation Engineer, include, but are not limited to the following:
- Contribute on the preparation and review of the Validation Master Plan – Process and Cleaning
- Manage the validation requirements of Chanelle and third party suppliers and CMO’s
- Manage the preparation, review and issuing of Validation Protocols and Reports (this to include equipment, cleaning, process and computer system validation)
- To maintain and take responsibility for the cleaning validation strategy at Chanelle.
- To assume responsibility for the cleaning validation master plan confirming to accepted practices and demands of the competent authorities in the EU.
- Implementation of Process Validation of new products for regulatory submissions ensuring compliance to proposed registered specifications.
- Coordination of the execution of Validation in accordance with protocols by Production, Quality Control and R&D teams
- Establishing, implementing and directing validation and revalidation activities
- Liaise with contract manufacture customers in seeking their approval for protocols and reports where appropriate.
- Reviewing and managing Change Control Forms for Validation implications
- Reviewing and managing Non-Conformances for Validation Implications
- Updating existing quality documentation related to validation activities.
- Identifying training requirements in support of validation
- Ensuring completion of validation protocols
- Carry out Internal Audits as required
- Responsible for the execution of Risk Assessments or Investigation reports relative to the role.
- Maintaining validation documentation system
- Required to Lead cross functional teams providing knowledge in resolution in any technical issues.
Assisting in the preparation and hosting of associated regulatory and customer audits
- Good verbal and written communication skills and the ability to work independently in analytical; environment.
- Good computer skills with Word, Excel and any other statistical programs
- Knowledge of Process and Cleaning Validation
- Ability to conduct internal audits.
- Ability to perform in external audits.
- Minimum Bachelor of Science or Engineering
- Experience within a pharmaceutical environment would be a distinct advantage.
- Highly organised with a strong attention to detail is essential.
- Ability to manage workload and work on own initiative.
- Ability to contribute effectively to a team environment.
- Strong communication skills to ensure effective relationships with external and internal customers.
- Excellent IT skills and computer literate preferably to ECDL level.