Specialist, Customer CARE

2 weeks ago

United Kingdom Dechra Pharmaceuticals PLC Full time

Summary Dechra Pharmaceuticals are looking for an experienced Validation Specialist to join our global manufacturing site.
You will be the site Lead for equipment, facility and utility validation to ensure regulatory compliance to established internal and external criteria.
The role expects you to offer support to the technical, QC and operations teams with validation as required, particularly with implementation of new equipment.
Prepare, coordinate execution and review protocols and quality risk assessments associated with validation activities to a compliant, cGMP standard
Responsible for initial and annual requirements such as thermal mapping and heat penetration studies, clean room qualification inc. Trouble-shoot and provide recommendation and solution for identified validation and qualification issues based on sound and knowledgeable analysis
Work with production and planning to schedule the necessary qualifications/re-qualification's with minimal impact on the manufacturing schedule
Remain current on legislative, regulatory and technical changes within the industry
Represent the company at customer and regulatory inspections (including VMD & FDA) and respond to questions
Ensure the Quality Systems metrics associated with Validation are maintained within agreed limits according to the site performance indicators
To perform other duties as may be reasonably requested and agreed with Senior Management
Support quality and productivity improvements
Contribute towards reducing product cost movements through the improvement of production utilisation and ensuring continuous improvement
Support in ensuring department outputs (KPI's) are met and that established cGMP quality standards are adhered to at all times
Ensure all waste is disposed of safely and in line with company processes, recycling wherever possible
Experience of validation and qualification in the Pharmaceutical industry
Proven industry experience from a highly regulated GMP manufacturing/packing facility, either from the Pharmaceutical or similarly regulated industry/environment
Strong technical writing skills with a thorough understanding of good documentation practice
Work collaboratively across a matrixed organization in a fast-paced manufacturing environment with the ability to communicate effectively both with the team, and with other areas

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