KEY RESPONSIBILITIES:

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. 

QUALIFICATIONS:

• 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

COMPETENCIES:

• 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. 

Work Environment 

• Office