Compliance Lead / QP
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.
Reporting to the Head of Quality, the Compliance Lead / QP will be responsible for developing, implementing, auditing and maintaining Compliance within Chanelle Pharma according to EU GMP/GLP. Overall responsibility for the assurance of continued compliance within the Quality Department & cross functional Teams
1.Responsibility for batch release as per EU and US FDA guidelines by ensuring the following requirements have been met:
- the batch and its manufacture comply with the provisions of the marketing authorisation (including the requirements for importation where relevant);
- manufacture has been carried out in accordance with GMP (in the case of an imported batch that it has been manufactured to standards equivalent to EC GMP);
- the principal manufacturing and testing processes have been validated (account has been taken of the production conditions by review of the relevant documentation);
- any deviations or planned changes have been duly authorised. Any changes requiring variation to the marketing authorisation have been notified and authorised by the relevant authority.
- all the necessary checks and tests have been performed.
- all necessary production and Quality Control documentation has been completed and endorsed by the appropriate staff;
- Forward any incoming reports (whether it is through post, e-mail, fax or in Person) regarding Pharmacovigilance / Adverse Action Reports to the relevant QPPV in a timely manner.
- all audits have been carried out as required by the QA system;
- take into consideration any other relevant factor that may affect the quality of the batch.
- Responsible for ensuring that company licenses are upheld.
- Assist the Head of Quality in hosting Regulatory inspections and Customer audits.
- Ensure that corrective actions identified as a result of observations raised during regulatory & customer audits are implemented in a timely manner.
- Ensure continued review of CAPA effectiveness
- Keep up with regulatory developments within or outside of the company as well as evolving best practices in compliance
- Ensure that all GMP related documentation is regularly reviewed and updated in accordance with Company policy and in line with Pharmacopeias, specifications EU GMP / FDA Guidelines and industry standards
- Review and approve company standard operating procedures.
- Provide monthly measurements on Key Performance Indicators (KPI’s) for Authority and Customer Audit CAPA responses
- Publish Metrics to Senior Management Team within Chanelle Pharma on a monthly basis
- Ensure that continuous improvement initiatives are identified and implemented across departments as appropriate.
- Conduct internal audits across the Functions of Chanelle Pharma.
- Establish cross functional team to ensure continued compliance within Chanelle Pharma GMP functions
- Conduct regular GMP walks of the facility ensure continued compliance to Chanelle internal policies and procedures
- Conduct external audits of suppliers and contract manufacturers in line with company audit schedule.
- Conduct main customer audits, review CAPA actions and oversight trends
- GMP training preparation and execution as required; Annual GMP Training (site and supplier) and Training in the QMS processes as required.
- Conduct performance reviews with QA personnel in accordance with the Company performance management system.
- Overview and assistance of the Quality Management System documents
- Support vendor qualification program including initial and ongoing qualifications to ensure quality oversight of GxP Vendors
- Any other duties assigned by the Head of Quality.
- 3rd level qualification – Bachelor’s degree in a science-based discipline.
- Minimum of 5 years in a pharmaceutical’s environment.
- Strong computer skills in MS Office
- Experience working within a pharmaceutical cGMP Environment; with knowledge of EU GMP and US FDA Guidelines
- Organisational skills, personal efficiency, time management skills and the ability to prioritise competing demands.
- Ability to lead teams and manage diverse personalities and viewpoints.
- In-depth knowledge of the industry’s standards and regulations
- Excellent communication skills, both verbal & written.
- Ability to prioritise decision making differentiating between urgent and non-urgent.
- Maintains the highest standards of ethical behaviour. Escalates issues appropriately.
- Practical, action-orientated approach to managing priorities.
- Takes a methodical, systematic, and structured approach to organising work.
- Strong Technical and troubleshooting ability.
- Strong Report Writing and presentation skills.