PURPOSE & SCOPE OF THE POSITION
The Validation Specialist will contribute to developing Symbiosis’ mutually beneficial relationships by:
- Supporting 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
- Effective communication skills
- Flexible and adaptive team player
- Ability to perform multiple tasks effectively in a busy environment
- Ability to train and direct a team
- Able to demonstrate problem solving, decision making and influencing skills
If you would like to apply for this role, please send your CV and cover letter, detailing your salary requirements to firstname.lastname@example.org
- Support the Site validation activities within a cGMP facility by maintaining the equipment/process qualification status to an agreed schedule.
- Ensure you work to and comply with all validation policies and procedures
- Assist with the preparation and issuing of relevant controlling SOP’s / Protocols / Reports
- Present the Validation status at the Quality Review Board when required.
Compliance & Quality Management
- Define and execute all tasks in line with Health and Safety standards.
- Present relevant reports and procedures at Regulatory and Client audits.
- Assist, where required with Quality Management activities / investigations
- Keep abreast of industry standards and trends in validation, providing in house guidance and training as required.
- Support the execution of Qualification activities around the Sales & Manufacturing schedule ensuring ongoing equipment availability and minimised disruption of the operation.
- Act as a back-up for the Manufacturing team, ensuring qualification for clean room access and support activities
Management & Development of Team
- Support the induction of the Validation staff to ensure they are clear about how they contribute to Symbiosis and can operate at their best.
- Understand the team’s needs, capabilities and preferred ways of working, and provide them with support and feedback.
- Attend, participate and contribute to regular staff meetings, as necessary.
- Invest in developing relationships with the management team to ensure we are a high performing team and Symbiosis’ services meet expectations.
- Act as an ambassador for the company.