Validation Officer

at  SFI Health

JJob purpose:
This role is responsible for ensuring compliance with all relevant legislation and ensuring the Quality System is fit for purpose to deliver business goals.
Reporting directly to the Head of Quality, the jobholder is responsible for organisation, execution, reporting and review of all aspects of validation and qualification process and activities across site including but not limited to; Equipment, Facility, Utility, Cleaning, Computer Systems, Shipping, and Analytical Methods.

MINIMUM REQUIREMENTS / QUALIFICATIONS

Extensive knowledge of GMP environments, particularly in a pharmaceutical background.
Process analysis skills suitable to collect / analyse data leading to process improvements.
Strong ability to analyse problems and define solutions.
· Good interpersonal skills.
· Effective communication.
· Excellent protocol and report writing skills, including written English.
· Knowledge of MHRA, FDA, and Eudra guidelines.
· Strong working knowledge of relevant computer systems including MS Office, Microsoft Word, Excel, SharePoint, PowerPoint), Track Wise and SAP.
Job Types: Temporary, Fixed term contract, Temp to perm
Contract length: 06 months
Pay: From £40,000.00 per year

Benefits:

• Company pension
• Flexitime
• Free parking
• Referral programme
• Sick pay
• Work from home

Schedule:

• Day shift
• Monday to Friday
• No weekends

Work Location: In perso

• Review Site Validation Systems against cGMP requirements to ensure compliance, including:
• Validation Master File.
• Asset List and equipment validations.
• Process validation protocol and report templates, procedures and status.
• Analytical Test Methods, including validation status, analytical method validation protocol and report templates.
• Cleaning Validation protocol and report templates.
  · Spreadsheet validation protocol and report templates. Validate critical spreadsheets.
  · Execute seasonal site temperature mapping.
  · Execute seasonal transport temperature mapping.
  · Execute stability cabinet temperature mapping.
  · Lead ongoing validation of new equipment on site.
  Other tasks as necessary to maintain the effective functioning of validation activities across site.
  To support the Quality Control Department with analytical method validation and verification activities including cGMP and regulatory compliance, and documentation (protocols, reports, data integrity).
  Other roles as business needs.