PURPOSE & SCOPE OF THE POSITION
Contribute to developing Symbiosis’ mutually beneficial relationships by supporting the on-site Validation team with the delivery and control of all site validation activities, to ensure compliance levels associated with a cGMP facility are achieved.
Educated to a degree level in a scientific discipline
- Knowledge of validation principles within a GMP environment, including hands-on protocol writing, execution, sample coordination and report writing skills
- Specialist validation knowledge and experience in equipment validation (Autoclaves/Ovens/HVAC/Freeze Driers/Equipment Washers) and / or process / computer validation
- Knowledge of freeze drier operations
- Knowledge of pharmaceutical manufacture
- Strong interpersonal communication skills with excellent technical writing abilities
- Experience in MHRA approved parenteral manufacturing operations
Assist and support with the effective delivery of site validation activities by maintaining the equipment/process qualification status to an agreed schedule
Work to and comply with all validation policies and procedures
Assist with the preparation and issuing of relevant controlling SOP’s / Protocols / Reports
Compliance & Quality Delivery
Assist with the control and monitoring of validation contractors
Assist the Validation team with Quality Management activities/investigations
Management & Development of Team
Assist the Manufacturing Team with the induction of staff to ensure they are clear about how they contribute to Symbiosis and can operate at their best.
Understand the other team members’ needs, capabilities, and preferred ways of working, and provide them with support and feedback.
Attend, participate and contribute to regular staff and management meetings, as necessary.
Invest in developing relationships with all staff to fully understand staff’s technical & process support needs and develop my colleagues accordingly.
Act as an ambassador for the company.
- Effective communication skills
- Flexible and adaptive team player
- Ability to perform multiple tasks effectively in a busy environment
- Able to demonstrate problem-solving, decision making, and influencing skills