Reporting to the GMP Manager, the role of the Senior GMP Inspector is to assist in the management, development and operation the HPRA GMP inspection processes; to achieve required levels of performance; and to respond effectively to changes in the internal and external environment.
In conjunction with the GMP Manager, the Senior GMP Inspector manages the overall performance of the GMP inspection team by defining objectives, setting targets, coordinating activities, agreeing priorities, developing team members, maintaining effective communication lines; and ensuring that the required standards, policies and practices are in place.
The Senior GMP Inspector provides leadership, motivation, encouragement and effective management for all staff reporting to him/her and ensures the maintenance of a positive working environment within the team.
The Senior GMP Inspector carries out GMP inspections and scientific evaluation across the full range of manufacturing and testing sites in accordance with the requirements of GMP, as defined in national legislation and in EU Directives, Regulations, national legislation and guidelines.
The Senior GMP Inspector provides information and advice to relevant individuals and organisations both internal and external to the HPRA.
The Senior GMP Inspector is responsible for managing systems and procedures to support GMP inspections and for the conduct of national and international inspections to assess the compliance with relevant legislation and guidance.
The Senior GMP Inspector maintains effective working relationships between the GMP inspection team and other areas of the HPRA, ensuring that any required interactions are adequately defined and effectively managed.
QUALIFICATIONS AND EXPERIENCE
- The successful candidate must have:
o 3rd level degree in biotechnology, pharmacy or other relevant life science discipline
o Minimum of 4 years relevant work experience, including;
- Working in a facility that manufactures biotech and/or sterile medicinal products in any of the following: quality assurance, compliance, quality control, production, technical services or validation, and/or,
- Conducting GMP inspections at manufacturers of biotechnology or sterile medicinal products.
o Knowledge of validation requirements including facility and equipment qualification and process, computer and assay validation
o Inspection / audit experience
o A valid full driver's licence and vehicle
In addition to this the ideal candidate will also have;
o Worked as a Qualified Person
Salary: €83,497 per annum. (*new entrants - incremental scale). July 2018
55-80 Days per annum
The new Single Public Service Pension Scheme ("Single Scheme") commenced with effect from 1 January 2013. All new entrants to pensionable public service employment on or after 1 January 2013 are, in general, members of the Single Scheme.
HOURS OF DUTY
The hours of duty are fixed by the HPRA from time to time. The current arrangements are Monday-Friday (minimum 37 hours). Appointees are eligible to participate in the flexitime arrangements after a period of six months.
DURATION OF POST
This is a three year fixed term contract.
Annual leave (exclusive of usual public holidays) is 25 days per annum.
VOLUNTARY HEALTH INSURANCE SCHEME
A group scheme operates for those wishing to participate and contributions are deducted from salary.
Applicants attending for interview may be required to prepare a presentation/complete a practical test - details will be notified to applicants who are shortlisted.
It is anticipated that interviews for this post will take place on the 5th September 2018.
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales