We are recruiting for a Head of Validation, this is a senior role based in London which will take on the day to day management of the validation team and reporting into the Director of Quality. Salary is up to £45,000.
What you’ll do:
Prioritise workload/resource using appropriate systems and information to ensure validations are performed effectively and within agreed lead-times.
Provide effective membership of the Quality Validation team, both at a personal level and through the team structure to support the achievement of team goals.
Act as a leader to teams to drive continuous improvement through effective leadership and ensure all relevant procedures are in place and enhanced to facilitate improvements.
Via networking with external experts/ new FDA and EU legislation, ensurerelevant best practices are identified and implemented
- This role has QA involvement with a number of sites at our client, this will involve deviations and CAPA’s for all GMP impacting areas of our client. The in depth duties and responsibilities of this role are outlined below.
- Day to day management of the Validation Team to ensure effective and efficient use of resource to fulfil the validation (methods, process, equipment, cleaning, facilities, computers) requirements for the site.
- To review, develop and improve current validations and to ensure all processes, equipment, cleaning methodologies, utilities/facilities, computer, analytical methods are validated and where required, such validations are performed in compliance with company quality objectives, GMP and other statutory/ regulatory requirements.
- Support the implementation of a Quality and Compliance Excellence program for the site, particularly the achievement and maintenance of 100% validation status ALL Validation
- Clear, effective liaison and communication with suppliers of information and internal/ external customers to ensure validations are managed in accordance with current guidelines and standards.
- To effectively manage / execute validation projects and provide commissioning, qualification and validation (CQV) support to new and ongoing projects across site.
- To ensure validation and revalidation requirements are identified and implemented and processes and/ or equipment remain in a validated state in accordance with legislative requirements.
- Provide QA input to various other projects on site as required in the maintenance of company Quality Systems with respect to validation, and compliance or as deemed necessary by Quality Management.
- To maintain relevant SOPs, master validation plan (MVP)/ Master Validation reports and associated secondary validation documentation and by so doing ensure the timely issue and continuous maintenance of the Site Validation Master Plan and system in an "inspection ready" status.
- To participate in the developments and technical transfer of new products as required. Support other site QA compliance activities such as self inspection compliance, Product Quality Reviews, Technical Agreement compliance, Pharmacopeia compliance, File compliance
- Participation in development and achievement of site Validation KPI's. Ensure the DDD/Fleet site validations are in compliance / in “inspection ready” status and ensure transparent reporting of status against plan objectives, with focus in a risk based fashion and linked to overall site performance.
We are seeking a candidate with a strong background in pharmaceutical validation who can act as a subject matter expert with strong awareness of legislation.
You will be keeping yourself at the vanguard of changes with a track record in ensuring best practices are adhered to. We seek a highly detail orientated individual, with excellent communication skills.
To apply, please email firstname.lastname@example.org or call 0161 300 9192 with any informal questions you may have. On this occasion, LiCa Scientific Ltd is acting as an employment agency.