Job Reference: J5635337
Updated On: 13/10/2021
Status: Now Interviewing
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Role OverviewAre you an experienced Process Validation Specialist looking for a new job opportunity?
We are currently looking for a Validation Specialist to join a leading pharmaceutical company based in the West Yorkshire area.
As the Validation Officer you will be responsible for the execution of validation protocols according to the Validation Masterplans and schedule in Process Validation and Equipment Qualification
Key Duties and ResponsibilitiesYour duties as the Process Validation Specialist will be varied however the key duties and responsibilities are as follows:
1. Liaise with Manufacturing, Engineering, Quality Assurance and User Departments to ensure that validation is tracked and completed in accordance with the Site Validation Master Plan.
2. Ensure the timely creation, approval and execution of qualification and validation protocols as required to meet the business needs, including the on-site purified water system. Plans and protocols are well-defined and appropriate testing standards and acceptance criteria are clearly specified.
3. Define the Process Validation program in line with regulatory expectations and manage Process Validation activities in line with predefined plan. Report significant changes/delays or failures to qualification/validation exercises to the Senior QA Validation Officer.
4. Work as part of a multifunctional team in conducting risk assessments to identify qualification and validation requirements for new products and changes to product, processes and equipment.
Role RequirementsTo be successful in your application to this exciting opportunity as the Process Validation Specialist we are looking to identify the following on your profile and past history:
1. As the Process Validation Specialist you will be degree qualified in either a Scientific or Engineering discipline.
2. Proven industry experience as a Process and Equipment Validation Specialist within a highly regulated cGMP manufacturing environment, such as the Pharmaceutical, Biotechnology or Medical Device industry.
3. Previous experience with the creation, approval and execution of qualification and validation protocols.
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