Principal Duties and Responsibilities:
- Co-ordination of samples for internal testing.
- Maintain regular consistent and professional attendance, punctuality, and personal appearance and adhere to relevant GMP and health and safety procedures.
- Ensure all operations are carried out in accordance with cGMP guidelines.
- Preparation of all validation protocols and reports for equipment qualification, process validation and cleaning validation as requested by the QA Manager.
- Complete Validation projects as per the Validation Master Plan and understand the objective of projects fully.
- Maintain all data-loggers in a calibrated state.
- Monitor temperature and humidity conditions within the plant and preparation of associated reports.
- Review and update SOP’s as necessary.
- Maintenance of the external and internal calibration programme.
- Liaise with other departments to progress specific validation projects in a timely manner.
- Liaise with external contractors in ensuring calibrations are carried out within specific time frames.
- Liaise with production in arranging sample requests from different products.
- Liaise with maintenance in completion of equipment qualification.
- Liaise with QC laboratory to ensure all relevant samples are available and tested as per pre-approved protocols.
Skills & Experience:
- Ability to prioritise, demonstrating good time management skills.
- Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
- The role demands a well-organised 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
- 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.