Validation Associate

Recruiter
Kingston Barnes Ltd
Location
swindon
Salary
£32000 - £35000/annum £32,000 - £35,000
Posted
14 Jul 2017
Closes
13 Aug 2017
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Validation Associate
Swindon Based (Multi Sited Including international travel)
£32,000 - £35,000

Due to significant ongoing growth, our client is seeking an experienced validation specialist to join their multi million pound organisation.
In order to achieve and maintain validated state of computer systems, equipment, facilities, utilities, processes, analytical methods and equipment.
Reporting into the Validation Manager, the successful associate will take responsibility for validation process improvements to increase efficiency and compliance to EU GMP standards.

Responsibilities

• Responsible for generation, updating and management of the Site Validation Master Plan, ensuring compliance of the plan with EU GMP.
• Responsible for the generation, issuing and control of Validation Documentation (USR, IQ, OQ ,PQ and Validation Reports)
• Site validation status, ensuring all facilities, systems, processes and equipment is maintained in a validated state.
• Planning and scheduling Validation activities.
• Carrying out Validation and Qualification activities on facilities, systems, processes and equipment in conjunction with the Production and Engineering Departments.
• Providing guidance and training to Production and Engineering personnel during validation execution.
• Generation of Change Controls for the introduction of new equipment and changes in equipment/facilities/processes or systems.
• Completion of CAPA assigned.
• Liaise with the customer for new product introductions and routine product re-validations.

Skills and Qualifications

• Degree in a scientific or engineering discipline or equivalent industry experience.
(Minimum of 2 years validation experience.)
• Experience and knowledge of cGMP.
• Knowledge of the regulatory requirements for areas of expertise.
• Competent in computer software packages Microsoft Office (Excel, Word, Powerpoint and Outlook).
• Strong interpersonal skills.
• Strong team player and also able to work effectively individually.
• Ability to plan, organize and control workloads of self to meet deadlines and deliver schedule and targets.
• Good communication skills at all levels both written and verbal.
• Ability to make decisions in a timely manner.

Additional Requirements

• To comply with all GMP processes and requirements.
• To comply with all health and safety requirements for yourself and others.
• To fulfil any other duties as required for your job role.
• Valid UK driver’s license.
• Ability to travel both domestically and overseas.

The company

A unique multi million pound UK based pharmaceutical and contract packing business housing c.600 personnel site with projected growth for a new build with c.50 flow lines