- Prepare, coordinate execution and review protocols and quality risk assessments associated with validation activities to a compliant, cGMP standard
- Support the site with validation activities as required
- Responsible for initial and annual requirements such as thermal mapping and heat penetration studies, clean room qualification inc. non-viable particle counting, warehouse temperature mapping studies & drying oven qualification activities
- Documentation and remediation of deviations resulting from validation/qualification studies
- Prepare and update validation associated SOPs
- 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
- Manage the maintenance of the validation equipment in a qualified/calibrated state
- 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
- Take reasonable care of both your own health and safety and that of others who may be affected by your acts or omissions, ensuring all company safety requirements are followed and all relevant legislation complied with, raising concerns and reporting any incidents or suggestions to your line manager
- Ensure the workplace environment is maintained to a high standard of cleanliness and tidiness, and complies with company and legislative standards 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
- Ability to prioritize multiple tasks/functions effectively in a global, multi-site organization
- 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
- A working knowledge of continuous improvement activities and ability to manage time and workload effectively is a benefit
- Good knowledge and understanding of Health & Safety compliance
Validation Specialist - Skipton, United Kingdom - Dechra
Found in: Talent UK C2 - 1 week ago
Description
Job Introduction
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.
Your duties will also make you responsible for developing the overall validation program within Dechra and providing guidance in establishing and maintaining cGMP compliant processes and site validation master plan. The role expects you to offer support to the technical, QC and operations teams with validation as required, particularly with implementation of new equipment.
The role will be based onsite at our Skipton location.
Role Responsibility
The Ideal Candidate