Quality Systems & Compliance Specialist (Supplier Assurance)
Responsible for the Supplier and Vendor assurance programme and associated activities
GMP Compliance Support
- Act as SME for the Supplier and Vendor assurance programme
- Maintain and keep the sites Approved Supplier List (ASL) up to date and in compliance with cGMP
- Represent the Swindon site in working with the corporate supplier assurance function
- Ensure all quality documents applicable to the Supplier and Vendor assurance programme are current and compliant with corporate standards and cGMP
- Undertake supplier/vendor audits ensuring they are tracked, planned, executed and reported in a timely and compliant manner
- Provide responses and CAPA plans to audit and/or inspections observations related to the Supplier and Vendor assurance programme
- Provide QMR input and metrics on the Supplier and vendor assurance programme
- Ensure KPI's and Supplier and Vendor scorecards are defined, tracked, reported and kept under control
GMP Compliance Support
- Use GMP technical knowledge to write and prepare GMP documents relevant to the site
- Use GMP technical knowledge to advise on GMP procedure simplification and training development
- Train and support training in general GMP standards and specific GMP areas in your area of expertise
- Ensure own KPI's, plans, targets and objectives are effectively monitored and achieved
- Support audits and inspections as part of the Q Systems audit and inspections response team
- Implementation of continuous improvement of GMP processes
- Support projects within the department and cross functional on the site and/or within the network
- Support and undertake other QA related tasks when required
- Undertake and support Self-inspections and GEMBA walks
- Stay up to date with corporate requirements, best practice and regulatory rules and regulations (within area of responsibility)
- Act and behave as in accordance with the company's 4i values
- Deputise for other QAO's in the department
- Understand emergency procedures and comply with safe systems of work.
- Ensure compliance with environment, health and safety rules, signage and instructions at all times.
- Ensure prompt reporting and investigation of all accidents, near misses and breaches of rules.
- Relevant science based degree; e.g. Chemistry, Biology, Pharmacy or equivalent
- Working knowledge of the principles and guidelines for cGMP as set out in the 'Orange Guide'
- Good knowledge of cGMP requirements for Supplier and vendor management desirable
- Experienced auditor - not essential
- Excellent writing & Communication skills