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Role Overview
Are you an experienced Validation Specialist looking for a new exciting job opportunity?
We are currently looking for a Validation Specialist to join a leading pharmaceutical company based in the Caerphilly area.
As the Validation Specialist, you will enhance validation practice and compliance; support improvement to validation system; streamline processes. Identify risk areas and required mitigation to meet regulatory inspections e.g. MHRA, FDA, Notified Body, etc., through routine compliance activities and specific validation projects.
Key Duties and Responsibilities
Your duties as the Validation Specialist will be varied; however, the key duties and responsibilities are as follows:
1. You will be responsible for ensuring that the Site Validation Master Plan is maintained accurately and Validation Plans are implemented for all relevant aspects of Equipment, Process, Cleaning, Computer Systems, Facilities/Utilities, and Analytical Method validation.
2. Additionally, you will assist with all validation activities on equipment before handover/return to system owner and update all relevant records and schedules. You will also be responsible for arranging specialist services to maintain, calibrate, and qualify specialist equipment.
3. You will provide technical input into all Validation Lifecycle activities as part of a cross-functional team. Provide guidance and support to other internal site departments ensuring compliance with applicable regulatory requirements (MHRA, EU, FDA, U.S., Notified Body, and international), Standards, and quality/validation regulations and guidance documents.
4. You will prepare and present validation reports and Key Performance Indicators for management review. Review and monitor trends; initiate continuous improvement opportunities; communicate any matters outside the norm to the Validation Manager / Site Director of Quality.
Role Requirements
To be successful in your application for this exciting Validation Specialist role, we are looking for the following on your profile and past experience:
1. Successful validation experience in a GMP environment (pharmaceutical, medical devices, consumer healthcare, or semi-conductor industry) is essential. Experience working in a sterile manufacturing facility would be highly desirable.
2. Demonstrated expertise in cGMPs, EU/FDA regulations, GAMP guidelines, risk assessment, and drafting of plans, protocols, reports, and procedures.
3. Previous team leadership experience (direct or indirect) desirable, operating in a matrix organization.
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