Engineering Projects and Compliance Manager

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. 

The Opportunity:

This is an opportunity to be part of a dynamic team within the Engineering and Maintenance 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.

This role involves the effective management of the Engineering project and engineering compliance team function at the Chanelle group site, ensuring delivery and compliance of capital projects including Buildings and Equipment, and ongoing compliance of existing buildings, utilities and equipment. As well as this, it involves performance management of the engineering compliance team, planning/execution and monitoring of project deliverables of the engineering office team including compliance management reporting to the Director of Engineering. 

KEY RESPONSIBILITIES:

• Management of the engineering office team executables including execution of capital and
maintenance projects from capex application preparation to hand over to production, operational
compliance to GMP including change control management, and validation life cycle documentation creation and execution, close out of internal audits, external audits, contractor engagement and
scheduling, project engineering project management, corrective action and preventative action reports and specialist engineering reports.
• Management/training and guidance of the engineering office team through effective
coaching/teaching and direction of the team to meet project and compliance KPI’s within the agreed budget limits.
• Management of projects to agreed timelines and costs. Projects entail capital facility and equipment
alterations and additions on the campus in FDA and HPRA regulated facilities.
• Ensure contractor and project compliance to safety requirements Liaising with sub contractors/suppliers where necessary.
• Ensure compliance to documented procedures and cGMP requirements are maintained at the
highest possible standards.
• Preparation of engineering procedures as required where appropriate to meet compliance
requirements and/or project KPIs .
• Achievement of KPIs as outlined in Performance and Development Plan.
• Implementing suggestions for improvement of the Quality System where applicable.
• Ensuring all existing procedures which are part of our quality system are adhered to.
• Ensure validation status of the plant and facilities is maintained e.g. air handling.
• Management of service contractors such as operations calibrations.

PHYSICAL DEMANDS:

Health & Safety requirements (eg. Manual Handling Training)
• Manual Handling

WORK ENVIRONMENT: (eg. Office, Production)

• Site wide and travel of site to meetings/shows/f.a.t.s from time to time depending on
business needs.

Engineering Projects and Compliance Manager

Galway