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.
This is an opportunity to be part of a dynamic team within the Quality 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.
The PV Auditor will be responsible to effectively manage and conduct internal and external (third-party) audits to assure compliance with applicable Chanelle Pharma procedures and local and global regulatory requirements as well as contractual agreements.
- Effective management of pre-audit activities: Communication with Auditee, preparation of Quality plan, Audit plan, Audit checklist, etc. in agreed formats and timelines;
- Conduct pharmacovigilance audits initiated by Chanelle Pharma, according to the agreed Audit Programme and in line with agreed Audit plan and Quality plan:
o Audits of Partners and Service Providers;
o Audits of Projects and Activities.
- Document audit findings and recommendations and identify process improvement initiatives and document them in an Audit report in agreed formats and timelines;
- Plan, create and maintain Corrective and Preventative Action Plans if needed, on an assigned audit basis;
- Generate and monitor audit metrics and performance evaluation.
- Act as Lead Auditor on an assigned audit basis: Review performance of pharmacovigilance audits, ensuring that audits comply with applicable Chanelle Pharma procedures and local and global regulatory requirements as well as contractual agreements.
- Support audits and inspections of Chanelle Pharma performed by clients/third parties and regulatory authorities;
- Participate in preparation (authoring or QC) of audit strategy, SOPs, guidelines and other documented procedures required for auditing activity of Chanelle Pharma ;
- Keep up-to-date with the relevant regulations, legislation of Pharmacovigilance, participate in relevant seminars and trainings;
- Participate in workshops or trainings organised by Chanelle Pharma and create/develop and present training to Chanelle Pharma staff on applicable regulatory requirements;
- Perform other activities as required by the company management in the area of responsibilities and qualifications as stated above.
- Quality-oriented, quality-committed
- Excellent interpersonal and communication skills, including good presentation and report writing skills
- Meticulous attention to detail
- Self-motivation, determination and confidence in own abilities
- Ability to work to deadlines, under pressure
- Ability to work on your own initiative and as part of a team
- Degree in life sciences or healthcare
- Strong experience in Pharmacovigilance
- Previous auditing experience
- Knowledge of EU Regulations as well as Guidelines on Good Pharmacovigilance Practice (GVP) and ICH Guidelines
- Fluent knowledge of English; additional languages would be a plus
PHYSICAL DEMANDS: Health & Safety requirements (eg. Manual Handling Training)
Computer / VDU User