QA Compliance Officer
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.Â
The Opportunity:
An important role in the QA department, reporting directly to the QA Compliance/Qualified Person, the Compliance Officer will be responsible for reviewing and issuing of Supply Chain Management, Product Quality Review and provide a Regulatory support to a QP. Also the co-ordination of the execution of a different Compliance activities with the relevant departments within the Chanelle Group.
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
• Review of all specifications and process against registered documents
• Generation of associated procedures
• Notify customers of any changes to DMF/ CEP updates on commercial products.
• Communicate customer requirements to regulatory departments and follow up.
• Maintain current status of each product and list of customers.
• Support Customer and Regulatory audits and follow through with CAPA responses as appropriate.
• Preparation and maintenance of Product quality reviews as per schedule
• Provide technical support to the MAH for New Product Introductions and existing Products.
• Preparation and maintenance of Technical Agreements.
• Preparation and review of quality risk assessments.
• Support a vendor management team when required.
• Contributing to the overall improvement of the company from a Quality/GMP perspective with an emphasis on continuous improvement of the quality system.
• Preparation and review of Standard Operating Procedures, Preparation and review of Investigation reports and risk assessments
• Any other duties assigned by the Head of Quality.
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.
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PHYSICAL DEMANDS:
Health & Safety requirements (eg. Manual Handling Training)
- VDU
- Manual HandlingÂ
WORK ENVIRONMENT:
- Office
