QA Compliance Officer

QA Compliance Officer

Chanelle Pharma

Galway, Ireland

KEY RESPONSIBILITIES:

• Responsible for Quality Complaints Programme;
• Ensure timely acknowledgement of Customer Complaints and Appropriate logging within the QMS;
• Ensure reports are written and approved within the required timeframe;
• Forwarding any associated Product Quality Defects to the respective Pharmacovigilance department;
• Liaising with the HPRA for product quality defects reporting;
• Review/lead Process investigations/Risk Assessment Documents and ensure any such investigations are documented appropriately with relevant corrective actions, if necessary;
• Support with Review and approval of Compliance documents e.g. Deviations, SCARS and CAPAs;
• Conduct Routine Quality Audits of the facility to ensure compliance, be proactive in resolving issues which may arise;
• Conduct annual GMP training to respective GMP Areas as and when scheduled;
• Quality review and approval of MWO’s & PWO’s;
• Provision/Updating of existing Quality Procedures;
• Contributing to the overall improvement of the company from a Quality/GMP perspective with an emphasis on continuous improvement of the quality system;
• Preparing product quality review reports;
• To carry out GMP walks as required;
• Support during Quarantine and Recall activities;
• Support or where necessary lead Quality based projects including working as part of a multidisciplinary team as required;
• Participation in the self-inspections, internal and regulatory audits and ensuring necessary corrective actions are put in place;
• Support and participation in the monthly Quality Management & Review;
• Any other duties assigned by Quality Management.

COMPETENCIES:

• Takes direction and asks questions;
• Relates well to the rest of the team;
• Develops own technical skills;
• Takes a methodical, systematic and structured approach to organising work;
• Ability to prioritise decision making differentiating between urgent and non-urgent;
• Escalates issues appropriately;
• Offers to help others when needed and creates a sense of harmony in the team;
• Displays flexibility and shows willingness to learn and do that little bit extra;
• Excellent Report Writing Skills.

QUALIFICATIONS:

• Minimum Bachelor’s degree in a science-based discipline;
• Minimum of 2-4 years’ experience in a pharmaceutical manufacturing environment with working knowledge of EU GMP and US FDA Guidelines;
• Excellent written and verbal communication skills through English.

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Ireland      Manufacturing and Logistics      Quality Assurance      Chanelle Pharma