- Our company employs approximately 9,500 people and is listed on the Irish and London stock exchanges with a market cap in excess of €2 billion.
- In the year ended March 2012 our company had revenues of €10.7 billion and operating profit of €185 million.
- Our company is a leading healthcare business in Britain and Ireland with sales in excess of €300 million, over 800 employees and an ambition to be one of the leading players in the supply of products and services to the healthcare sector in Europe.
- Our company is focused on driving organic growth in its existing businesses and identifying new growth opportunities that strengthen and expand its product range, broaden its geographical reach and improve its business.
- Our company operates across three key divisions - Pharma, Medical Devices and Logistics:
The role requires a flexible individual contributor who works well in a team environment, and has necessary skills to organize, communicate and manage day-to-day work activity. The principal duties of the Compliance Officer is the successful completion of Product quality review, data tracking and trending and reviewing all Third Party manufacturing activities for compliance to the MA.
Principal Duties and Responsibilities:
- Ensure all operations are fully compliant with license details and updated in accordance with relevant guidelines and directives
- Review of internal documentation to ensure compliance with license details and relevant guidelines and directives.
- Coordinate the logging of all routine batch record data and ensure data is tracked for any notable trends.
- Develop work processes in conjunction with Release QPs, to aid the logging of all future routine batch record data.
- Initiate and investigate non-conformances as required where issues detected.
- Complete all Annual Product Quality Reports (PQRs) in conjunction with Third party CMO (Contract Manufacturing Organisation) manufacturers and contract laboratories.
- Review and approval of Third Party CMO Master Batch Records (Batch Manufacturing & Packing records, Validation/Stability Protocols and Report, Finished Product Specifications and End Of Shelf Life specifications).
- Ensure all Contract Manufacturing Organisations and Third Party testing sites hold a valid GMP Certificate.
- Prepare and Manage Quality Metrics on a monthly basis (QRG) and record all minutes and follow up actions (prepare relevant slides).
- Maintenance of the Validation and Stability Master Plans for all validation and stability activities carried out at Third Party CMOs.
- Complete Annual compliance reviews of Third Party CMOs manufacturing process, specifications, test methods, GMP licence, and validation status, Stability reporting and packaging specifications for compliance to the MA.
- Assure a safe and compliant work place by adhering to all EH&S procedures and reporting any health and safety issues as required.
- Track and investigate any assigned Non-conformances and complete all CAPA actions within agreed timeframes as appropriate.
- Facilitate personal development and employee engagement by completing performance appraisals and any resulting development plans.
- Comply with all training requirements as required by the job function.
- Liaise with other departments to ensure correct supporting data generated and provided in a timely manner
- Third Level qualification preferably in a scientific discipline
- A Working knowledge of quality systems requirements, HPRA, MHRA, EU regulations and ICH guidelines as they relate to Quality Assurance.
- The role demands a well-organized approach, underpinned by the ability to communicate effectively with people at all levels, both verbally and in writing. Reliability, IT literacy and the ability to plan and complete projects to set timelines is essential.
- Full-time, permanent role
- Excellent remuneration package commensurate with experience will apply
- In addition candidates should be:
- Available to work beyond normal office hours and weekends, including travel as required
- Although the above is a description of the requirements of the role, as stated in your contract of employment, you may be required to carry out other reasonable duties as the Company may require from time to time.
- Develop and maintain familiarity with applicable legislating, guidelines and current industry practice that impact GMP, GDP and Regulatory Affairs.